regulatory manager

CareFirst BlueCross BlueShield

<div>Resp &amp; Qualifications
PURPOSE:
 
This position is accountable for the oversight of the Mandates Regulatory Operations and Reporting team. Key responsibilities include gathering, analyzing and disseminating key sources of information on Association, Federal, State and Local legislation as well as the identification and definition of requirements for mandates compliance. This position will collaborate with Public Policy and Government Affairs (PPGA), Legal, Business and Enterprise Project Management Office (EPMO) to ensure that all mandate requirements are reviewed and agreed upon by stakeholders and implemented. This position is also accountable for overseeing, providing analysis and recommendations on mandates for strategic decision making both internally and externally, and for ensuring support of the company's business objectives and compliance. 
 
ESSENTIAL FUNCTIONS:<ul><li>
Accountable for the tracking, analysis and evaluation of new local, state and federal regulations Association mandates.</li></ul>
<ul><li>Maintains a comprehensive legislative tracker and monitors regulatory guidelines. For all mandates with CareFirst impact, determines if implementation is required and confirms whether for compliance or informational distribution only.</li></ul>
<ul><li>Tracks the achievement of CareFirst compliance status, timelines and integrating with EPMO project teams for execution of mandate implementation projects.
</li></ul><ul><li>Works with Legal, Business and EPMO to ensure project implementation activities result in compliance with mandates that are operationally plausible.</li></ul>
<ul><li>Manages annual regulatory operations projects that do not have a single business owner, such as MLR and Creditable Coverage Notification. Develops, maintains and oversees processes for tracking and reporting on these projects, ensuring timely and accurate completion.</li></ul>
<ul><li>Accountable for staffing activities including recruitment, interviewing, selection, and hiring qualified staff. Provides oversight and direction to the employees in accordance with the organization's policies and procedures.</li></ul>
<ul><li>Responsible for coaching, mentoring and developing staff, including overseeing new employee onboarding and providing career development planning and opportunities; including delegating as appropriate to direct reports.</li></ul>
<ul><li>Responsible for performance management and completion of annual performance evaluations. Provides timely performance feedback throughout the year via employee recognition, rewards and disciplinary action as appropriate. Maintains transparent communication and appropriately communicates organizational information through department meetings, one-on-one meetings, and appropriate email, IM, and regular interpersonal communication.</li></ul>
Accountable for reporting and documentation. Establishes and maintains auditable business processes for the efficient collection and submission of data required by regulatory bodies. Oversees the creation and submission of annual and ad hoc reports, ensuring that all data is accurately compiled and legally vetted. 
<ul><li>
</li><li>
Responsible for cross-departmental collaboration. Works closely with PPGA, Legal, EPMO, Compliance, and other departments to establish and maintain effective processes for the handoff and execution of regulatory work. Serves as a liaison between these departments to facilitate communication and collaboration.</li></ul>
<ul><li>Accountable for providing the VP Regulatory Operations and other business areas with relevant information for the purpose of strategic decision making by providing analysis and subject matter expertise on mandates.</li></ul> 
SUPERVISORY RESPONSIBILITY: 
This position manages people. 
 
QUALIFICATIONS: 
 
Education Level: Bachelor's Degree in Business or related field OR in lieu of a Bachelor's degree, an additional 4 years of relevant work experience is required in addition to the required work experience. 
Experience: 5 years in an IT and/or business role in a health insurance or regulatory compliance environment and 1 year supervisory or demonstrated progressive leadership experience. 
 
Preferred Qualifications:<ul><li>
Understanding of federal, state, and local legislative and regulatory processes, public policy analysis.</li><li>
Comprehensive understanding of the healthcare payor industry, insurance products, and regulation.</li>
Expansive knowledge of CareFirst operations. 
<li>
</li></ul> 
Knowledge, Skills and Abilities (KSAs)<ul><li>
Strong verbal and written communication skills, along with problem-solving, negotiation, and decision-making skills to influence management and internal/external partners.</li><li>
Demonstrated leadership abilities and effectiveness in matrix management. Strong management and team building skills.</li>
Excellent business analysis and process improvement skills. Ability to work well with all levels of management, including senior and executive levels. 
<li>
 
 
</li></ul> 
 
 
Salary Range: $112,960 - $209,682 
Salary Range Disclaimer
The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the work is being performed. This compensation range is specific and considers factors such as (but not limited to) the scope and responsibilities of the position, the candidate's work experience, education/training, internal peer equity, and market and business consideration. It is not typical for an individual to be hired at the top of the range, as compensation decisions depend on each case's facts and circumstances, including but not limited to experience, internal equity, and location. In addition to your compensation, CareFirst offers a comprehensive benefits package, various incentive programs/plans, and 401k contribution programs/plans (all benefits/incentives are subject to eligibility requirements).
Department
Corporate Governance
Equal Employment Opportunity
CareFirst BlueCross BlueShield is an Equal Opportunity (EEO) employer. It is the policy of the Company to provide equal employment opportunities to all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information.
Where To Apply
Please visit our website to apply: www.carefirst.com/careers
Federal Disc/Physical Demand
Note: The incumbent is required to immediately disclose any debarment, exclusion, or other event that makes him/her ineligible to perform work directly or indirectly on Federal health care programs.
PHYSICAL DEMANDS:
The associate is primarily seated while performing the duties of the position. Occasional walking or standing is required. The hands are regularly used to write, type, key and handle or feel small controls and objects. The associate must frequently talk and hear. Weights up to 25 pounds are occasionally lifted.
Sponsorship in US
Must be eligible to work in the U.S. without Sponsorship.
#LI-LJ1</div>

Regulatory Operations Manager (Remote)

TD Bank

<div>Work Location:
Mount Laurel, New Jersey, United States of America
Hours:
40
Pay Details:
$91,000 - $145,600 USD
TD is committed to providing fair and equitable compensation opportunities to all colleagues. Growth opportunities and skill development are defining features of the colleague experience at TD. Our compensation policies and practices have been designed to allow colleagues to progress through the salary range over time as they progress in their role. The base pay actually offered may vary based upon the candidate's skills and experience, job-related knowledge, geographic location, and other specific business and organizational needs.
As a candidate, you are encouraged to ask compensation related questions and have an open dialogue with your recruiter who can provide you more specific details for this role.
Line of Business:
Human Resources
Job Description:
This is a unique opportunity to lead the transformation of how TD delivers regulatory and compliance training across the U.S. Bank&mdash;reimagining required learning to be smarter, more targeted, and more impactful for colleagues. As a leader within U.S. Learning &amp; Development, you&rsquo;ll shape regulatory training practices, influence senior stakeholders, and drive innovative solutions that strengthen compliance and audit outcomes while addressing opportunities to manage the portfolio and its delivery efficiently. You&rsquo;ll sit at the intersection of learning, risk, compliance, and technology, using data and governance to modernize how required learning is designed, deployed, and measured. If you&rsquo;re motivated by solving complex problems, improving colleague experience, and playing a visible role in regulatory excellence, this role offers both scale and impact.
HR Program Manager leads the development and implementation of enterprise wide HR programs, including design, development, implementation, monitoring, reporting, and resolution of issues for a specialized functional area.
Depth &amp; Scope:
<ul><li>Highly seasoned professional role requiring substantial knowledge/expertise in a complex field and knowledge of broader related areas
</li><li>Integrates knowledge of the enterprise sub-functions or business lines overarching strategy in developing solutions across multiple functions or operations
</li><li>Interprets internal/external business challenges and the industry environment, recommends course of action and best practices to improve products, processes or services
</li><li>Acts as a technical expert/lead integrating cross-function understanding within their own field of specialty; may manage team(s) of related specialists
</li><li>Leads cross-functional teams or projects with significant resource requirements, risk and/or complexity
</li><li>Independently manages end-to-end functional programs
</li><li>Solves or may lead others to solve complex problems; leads efforts or partners with others to develop new solutions
</li><li>Uses sophisticated analytical thought to exercise judgement and identify solutions
</li><li>Impacts the achievement of sub-function or business line objectives within the area they are accountable for
</li><li>Work is guided by policies and industry standards/methods
</li><li>Communicates difficult concepts; converts information to compelling business context and advice; influences and gains alignment across increasingly senior stakeholders
</li>Works autonomously as the lead and guides others within area of expertise 
<li>
</li></ul> 
Experience:
<ul><li>Undergraduate degree
</li><li>7+ years of relevant experience
</li><li>Advanced knowledge of multiple HR specialties, HR strategy development, HR policy, consulting principles, lines of businesses supported, banking industry practices, regulations, standards, tools, methodologies
</li><li>Knowledge of current and emerging competitor and market trends
</li><li>Knowledge of risk management environment, standards and regulations
</li><li>Ability to lead, plan, implement and evaluate program/project activities to ensure completion of HR initiatives
</li><li>Ability to forecast and contribute to strategic direction of the HR function and provide advice to senior leadership
</li><li>Skill in preparing and managing budgets
</li><li>Knowledge of and/or skill in using analytical software tools, data analysis methods and reporting techniques
</li><li>Ability to exercise sound judgement in making decisions
</li><li>Skill in change management, able to lead teams through complex change from concept to execution
</li><li>Ability to make an impact, influence and achieve results with effective negotiation, problem-solving and communication skills
</li><li>Skill in public speaking and delivering presentations to individuals and groups
</li><li>Ability to communicate effectively in both oral and written form
</li><li>Ability to work collaboratively and build relationships across teams and functions
</li><li>Skill in using computer applications including MS Office
</li><li>Ability to analyze, organize and prioritize work while meeting multiple deadlines
</li><li>Ability to work successfully as a member of a team and independently
</li><li>Ability to handle confidential information with discretion
</li></ul>Preferred Qualifications:
<ul><li>Deep expertise in U.S. banking regulatory and compliance training, including required learning governance, regulatory expectations, and audit readiness.
</li><li>Proven experience leading or supporting regulatory exams, audits, or remediation efforts, with the ability to produce defensible learning evidence.
</li><li>Strong command of required learning strategy and execution, including role‑based training, targeted audience design, and lifecycle management.
</li><li>Hands-on experience with learning and HR systems (e.g., LMS platforms, Workday), including audience assignment logic, reporting, and issue resolution.
</li><li>Ability to analyze learning, completion, and exception data to inform risk‑based decisions and continuous improvement.
</li><li>Demonstrated success influencing across a complex, matrixed organization, partnering with Compliance, Risk, HR, and Lines of Business without formal authority.
</li><li>Strategic mindset paired with operational rigor, able to balance regulatory obligations with colleague experience and training efficiency.
</li><li>Strong judgment in ambiguous or high‑risk situations, especially where regulatory, remediation, and learning effectiveness intersect.
</li><li>Exceptional communication skills, with the ability to translate complex regulatory requirements into clear, actionable learning strategies.
</li><li>Experience driving innovation or modernization in required or regulatory learning, such as adaptive elearning, while maintaining strong outcomes.
</li>Leadership presence and thought leadership capability, contributing to enterprise standards, governance enhancements, and best practices. 
<li>
</li></ul> 
Customer Accountabilities:
<ul><li>Develops and executes diverse programs, implements and develops activities, tools and programs for businesses, and supports people strategy and management activities
</li><li>Manages, analyzes and draws insights from data to inform priorities and initiatives, including post-implementation reviews and program analysis to ensure solutions continue to meet HR strategy and vision
</li><li>Researches, analyzes and develops Best in Class solutions designed to address gaps and developmental priorities aligned to business needs and the TDBG people mandate
</li><li>Supports the implementation, management and monitoring of a consistent, disciplined processes/programs
</li><li>Supports the business in identifying and delivering against business and HR projects and initiatives by executing project management deliverables within budget and as per the approved project plan, working with business and HR partners to develop the content of those deliverables
</li><li>Supports regulatory applications by providing relative HR information for report to the applicable regulatory bodies/responding to requests for information
</li></ul>Shareholder Accountabilities:
<ul><li>Adheres to enterprise frameworks or methodologies that relate to activities for our business area
</li><li>Ensures respective programs/policies/practices are well managed, meets business needs, complies with internal and external requirements, and aligns with business priorities
</li><li>Consistently exercises discretion in managing correspondence, information and all matters of confidentiality; escalates issues where appropriate
</li><li>Ensures business operations are in compliance with applicable internal and external requirements ( e.g. financial controls, segregation of duties, transaction approvals and physical control of assets)
</li><li>Participates in cross-functional/enterprise/initiatives as a subject matter expert helping to identify risk/provide guidance for complex situations
</li><li>Conducts internal and external research projects; supports the development/delivery of presentations/communications to management or broader audience
</li><li>Monitors service, productivity and assesses efficiency levels within own function and implements continuous process/performance improvements where opportunities exists
</li><li>Leads/facilitates and/or implement actions/remediation plans to address performance/risk/governance issues
</li><li>Actively manages relationships within and across various business lines, corporate and/or control functions and ensure alignment with enterprise and/or regulatory requirements
</li><li>Keeps abreast of emerging issues, trends, and evolving regulatory requirements and assesses potential impacts
</li><li>Maintains a culture of risk management and control, supported by effective processes in alignment with risk appetite
</li></ul>Employee/Team Accountabilities:
<ul><li>Participates fully as a member of the team, supports a positive work environment that promotes service to the business, quality, innovation and teamwork and ensures timely communication of issues points of interest
</li><li>Provides thought leadership and/or industry knowledge for own area of expertise in own area and participates in knowledge transfer within the team and business unit
</li><li>Keeps current on emerging trends/developments and grows knowledge of the business, related tools and techniques
</li><li>Participates in personal performance management and development activities, including cross training within own team
</li><li>Keeps others informed and up-to-date about the status/progress of projects and/or all relevant or useful information related to day-to-day activities
</li><li>Contributes to team development of skills and capabilities through mentorship of others, by sharing knowledge and experiences and leveraging best practices
</li><li>Leads, motivates and develops relationships with internal and external business partners/stakeholders to develop productive working relationships
</li><li>Contributes to a fair, positive and equitable environment that supports a diverse workforce
</li><li>Acts as a brand ambassador for business area/function and the bank, both internally and/or externally
</li></ul>Physical Requirements:
Never: 0%; Occasional: 1-33%; Frequent: 34-66%; Continuous: 67-100%
<ul><li>Domestic Travel &ndash; Occasional
</li><li>International Travel &ndash; Never
</li><li>Performing sedentary work &ndash; Continuous
</li><li>Performing multiple tasks &ndash; Continuous
</li><li>Operating standard office equipment - Continuous
</li><li>Responding quickly to sounds &ndash; Occasional
</li><li>Sitting &ndash; Continuous
</li><li>Standing &ndash; Occasional
</li><li>Walking &ndash; Occasional
</li><li>Moving safely in confined spaces &ndash; Occasional
</li><li>Lifting/Carrying (under 25 lbs.) &ndash; Occasional
</li><li>Lifting/Carrying (over 25 lbs.) &ndash; Never
</li><li>Squatting &ndash; Occasional
</li><li>Bending &ndash; Occasional
</li><li>Kneeling &ndash; Never
</li><li>Crawling &ndash; Never
</li><li>Climbing &ndash; Never
</li><li>Reaching overhead &ndash; Never
</li><li>Reaching forward &ndash; Occasional
</li><li>Pushing &ndash; Never
</li><li>Pulling &ndash; Never
</li><li>Twisting &ndash; Never
</li><li>Concentrating for long periods of time &ndash; Continuous
</li><li>Applying common sense to deal with problems involving standardized situations &ndash; Continuous
</li><li>Reading, writing and comprehending instructions &ndash; Continuous
</li><li>Adding, subtracting, multiplying and dividing &ndash; Continuous
</li></ul>The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all responsibilities, duties and skills required. The listed or specified responsibilities &amp; duties are considered essential functions for ADA purposes.
Who We Are:
TD is one of the world's leading global financial institutions and is the fifth largest bank in North America by branches/stores. Every day, we strive to make every interaction, product, and experience remarkably human and refreshingly simple for over 27 million households and businesses in Canada, the United States and around the world. More than 95,000 TD colleagues bring their skills, talent, and creativity to foster deeper relationships, ensure disciplined execution, and build a simpler, faster banking experience. TD is deeply committed to being a leader in client experience, that is why we believe that all colleagues, no matter where they work, are client facing. Together, we are reimagining what banking can be for our clients, colleagues and communities.
Our Total Rewards Package 
 
Our Total Rewards package reflects the investments we make in our colleagues to help them and their families achieve their financial, physical and mental well-being goals. Total Rewards at TD includes base salary and variable compensation/incentive awards (e.g., eligibility for cash and/or equity incentive awards, generally through participation in an incentive plan) and several other key plans such as health and well-being benefits, savings and retirement programs, paid time off (including Vacation PTO, Flex PTO, and Holiday PTO), banking benefits and discounts, career development, and reward and recognition. Learn more
Additional Information:
 
We&rsquo;re delighted that you&rsquo;re considering building a career with TD. Through regular development conversations, training programs, and a competitive benefits plan, we&rsquo;re committed to providing the support our colleagues need to thrive both at work and at home.
 
 
Colleague Development
If you&rsquo;re interested in a specific career path or are looking to build certain skills, we want to help you succeed. You&rsquo;ll have regular career, development, and performance conversations with your manager, as well as access to an online learning platform and a variety of mentoring programs to help you unlock future opportunities. 
If you&rsquo;re passionate about helping clients and building deep, lasting relationships, TD offers diverse career paths where you can grow your expertise and make a meaningful impact.
We're committed to your success and foster a respectful workplace where diverse perspectives are valued, everyone has fair opportunities to grow, and you can unlock your full potential to achieve your career goals. Here at TD, we hire and develop the best.
Training &amp; Onboarding
 
We will provide training and onboarding sessions to ensure that you&rsquo;ve got everything you need to succeed in your new role.
 
 
Interview Process
 
We&rsquo;ll reach out to candidates of interest to schedule an interview. We do our best to communicate outcomes to all applicants by email or phone call.
Accommodation
TD Bank is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, status as a protected veteran or any other characteristic protected under applicable federal, state, or local law.
If you are an applicant with a disability and need accommodations to complete the application process, please email TD Bank US Workplace Accommodations Program at USWAPTDO@td.com . Include your full name, best way to reach you and the accommodation needed to assist you with the applicant process.</div>

Regulatory Training Manager, US

Grant Thornton

<div><div><h4 class="jobSectionHeader">Job Overview</h4>
<div>We&rsquo;re a large and growing professional services firm that still feels like a community. With over 76,000 professionals in more than 150 countries, we combine global scale with local expertise to help dynamic organizations unlock their potential for growth. We truly care about our colleagues, our clients, and the communities where we work and live.

As a Manager, you&rsquo;ll oversee the full spectrum of regulatory compliance advisory services for high-profile clients, manage project portfolios, and guide the team in achieving business objectives and maintaining client satisfaction. Discover your purple and join our Regulatory Advisory Team today!

Let us paint a picture for you

Imagine being part of a team that puts &ldquo;we before me&rdquo;, where flexibility is a mindset, and where you trust your colleagues to have your back.

Imagine working for an organization that believes in the power of authenticity in everything that we do. Whether you're steering discussions in a client meeting, tackling your fear of heights at the top of the Burj Khalifa or ziplining across Jebel Jais &ndash; bring your true self to work. Be a part of a team driven by a purpose of shaping the world that we live in, based on trust and integrity in markets, dynamic businesses, and communities where businesses and people thrive.

Join us to expand your horizons, be inspired, face challenges, and most importantly, be yourself.

About the Regulatory Advisory Service Line

Our Regulatory / Governance, Risk and Compliance Advisory practice supply a range of services to regulatory authorities, licensed financial institutions and other relevant organizations. Partnering with our colleagues in the wider Advisory, our work falls broadly into the following areas: Regulatory Compliance Advisory, Corporate Governance Advisory, Non-Financial Risk Management, Consumer Protection Advisory and Islamic Finance Advisory.

As a Manager some of your responsibilities will include:
<ul>
<li>Overseeing the delivery of regulatory / GRC advisory engagements</li>
<li>Providing high-level strategic advice to clients on regulatory and compliance matters</li>
<li>Leading the development of new service offerings and market expansion strategies</li>
<li>Representing the firm at industry events, conferences, and regulatory bodies</li>
<li>Planning the engagement approach and overseeing the delivery of the engagement from planning to completion, including performance review of the team members&rsquo; work</li>
<li>Contributing to business development efforts, including proposal development, client presentations, and training materials</li>
<li>Preparing detailed reports outlining project deliverables and where relevant professional recommendations</li>
</ul>
Think you've got what it takes to be a Manager? Like the color purple? Great. Here's a few more boxes we're also hoping you can tick:
<ul>
<li>7 + years of experience working in financial institutions, regulatory bodies, or consulting firms</li>
<li>Strong experience across GRC, regulatory compliance, corporate governance, consumer protection and internal audit &ndash; Islamic Finance is a plus</li>
<li>Demonstrated experience advising regulatory authorities and financial services clients, including banks, asset managers, and other regulated financial institutions</li>
<li>In‑depth knowledge of UAE financial regulatory frameworks, including hands‑on experience with the Central Bank of the UAE, Capital Markets Authority and other regulatory requirements</li>
<li>Experience supporting or leading regulatory compliance, corporate governance, non-financial risk management and consumer protection initiatives is strongly preferred</li>
<li>Specific exposure to Market Conduct, Consumer Protection and Islamic Finance regulatory and compliance frameworks is an advantage</li>
<li>Hold a leading professional qualification such as the ICA, CIA or Company Secretariat degrees
</li><li>Proven ability to operate in a client‑centric, high‑pressure environment and deliver complex engagements against tight deadlines</li>
<li>Exceptional stakeholder management and client relationship skills, with experience engaging senior management and boards</li>
<li>Strong analytical and problem‑solving skills, with the ability to interpret legislation, regulatory guidance, and supervisory expectations</li>
<li>Excellent written and verbal communication skills in English; Arabic is advantageous</li>
<li>Ability to thrive in a multicultural, diverse, and fast‑paced environment</li>
<li>Strong proficiency in Microsoft Office applications, usage of AI based tools is an advantage</li>
</ul></div>
<h4 class="jobSectionHeader">Skills</h4>
<div>.</div> 


</div><div></div><div><div><h4 class="jobSectionHeader">Job Details</h4>
<div><div>Job Location</div>
<div>Abu Dhabi, UAE</div>
</div><div><div>Job Role</div>
<div>Business Advisory</div>
</div><div><div>Joining Date</div>
<div>Jun-2026</div>
</div><div><div>Preferred Contract Type</div>
<div>Permanent</div>
</div></div><div><h4 class="jobSectionHeader">Preferred Candidate</h4>
<div><div>Career Level</div>
<div>Mid-Management</div>
</div><div><div>Highest Education</div>
<div>Bachelor's degree</div></div></div></div></div>

Manager | Governance, Risk and Compliance | Regulatory Advisory

Grifols Egypt for Plasma Derivatives (GEPD)

<div>
 
 Job Objective:
 
 
 
 Regulatory Affairs Senior Manager is the responsible for any communication and coordination with EDA , European Medicines Agency (EMA) and/or other International Health Authorities (as required).
 
 
 Liaison and support between regulatory bodies and operating divisions of the company. Responsible for reviewing and managing the regulatory function by ensuring compliance with (EDA), European Medicines Agency (EMA) and other International Health Authorities (as required), regulations and guidelines to obtain and maintain the corresponding approvals for any GMP area, including Plasma Supply Chain, Manufacturing facility, Exportation / Importation for plasma and/or Final Product in Egyptian Market or others (as required).
 
 
 
 Key responsibility:
 
 
 
 <ul>
 <li>
 Communication with local and international Health Authorities. Support, communication and coordination (as necessary) with local Health Authorities for Plasma Supply chain and Manufacturing facilities for the process of licensing, certification, exportation, importation, and finished product release.
 </li>
 <li>
 Ensure that applicable Health Authorities guidelines, rules and regulations are applied up to date, covering plasma or finished products or GMP sites and regulatory processes.
 </li>
 <li>
 Review and manage the licensing and GMP certification regulatory process for Plasma supply chain and manufacturing. Ensure any submissions related to local and international Health Authority are performed on time for initial licensing and renewal (if applicable) to maintain valid license and/ or certification is maintained in all facilities per existing regulations.
 </li>
 <li>
 Review all the documentations prepared to be submitted to EDA , International Health Authorities and any Certification entities.
 </li>
 <li>
 Change notification to Local and International Health Authorities.
 </li>
 <li>
 Change notification and customers related to Change Control implementation.
 </li>
 <li>
 To assist Direct Manager in any assigned duties.
 </li>
 <li>
 Manage Regulatory Affairs Area to ensure compliance with the above-mentioned points.
 
 
 
 </li>
 </ul>
 
 Academic &amp; Professional Experience Required
 
 
 
 <ul>
 <li>
 Bachelor s Degree in Health-related Sciences, preferably pharmaceutical area.
 </li>
 <li>
 Post-Graduate Certification in Quality Management.
 </li>
 <li>
 Knowledge of cGMP requirements preferred.
 </li>
 <li>
 Minimum of 4 years of Management or technical leadership experience is required.
 </li>
 <li>
 Minimum of 8 years of related experience in Regulatory Affairs field, including Pharma
 </li>
 <li>
 Manufacturing background, and Final Product importation and exportation experience.
 </li>
 <li>
 Preferably with experience on EMA Regulatory requirements and submissions.
 
 </li>
 </ul>
</div>

Regulatory Affairs Sr. Manager

Fairweather, LLC

<div>Overview:<div></div> 
Pay Status: Full Time Salary
FLSA Status: Exempt 
About Fairweather
Fairweather is a trusted service provider in Alaska, delivering specialized solutions in remote and Arctic environments. Our mission is to support operations with safety, integrity, and excellence. We offer a dynamic and inclusive work environment, ensuring our employees are equipped with the tools and support needed for success.
Why You Should Work for Us<ul><li>
Competitive compensation and benefits package</li><li>
Supportive and collaborative work culture</li><li>
Opportunities for professional development and career growth</li><li>
Commitment to employee safety and well-being</li></ul>
Total Rewards &amp; Benefits<ul><li>
Medical Coverage: Federal Employee Health Benefits (FEHB) plans, including medical, dental, and vision</li><li>
Retirement Plan: 401(k) up to 4% company match.</li><li>
Insurance: Short-term and long-term disability, life insurance, and voluntary supplemental coverage</li><li>
Employee Assistance Program (EAP): Free counseling and support services</li><li>
Paid Holidays: Observance of major federal holidays</li><li>
Flexible Spending Accounts: Health and dependent care options</li></ul> 
Job Summary
The Regulatory and NonTechnical Risk Manager (RNTM) is an experienced, motivated, and resourceful individual that develops reliable and efficient strategies focused on complex regulatory and permitting efforts on a variety of projects in Alaska. The RNTM will also provide leadership and direction to team members in executing and delivering sound science attributes associated with the regulatory landscape. 
Essential Duties
Identify Business Opportunities to provide regulatory, permitting and compliance services to clients in Alaska with the potential to expand to other parts of the US
Analyze requirements of Federal, State and Local governments to develop a comprehensive regulatory strategy to obtain timely, useable and fit for purpose permits in support of critical projects. Develop a plan including a stakeholder map to enable the efficient execution of a successful regulatory process. Identify the correct resources and develop and manage personnel effectively. Maintain strong communications and collaboration with clients, regulatory bodies and stakeholders.
Support Business Development by Identifying clients and aiding in securing contracts for Fairweather LLC to provide support and solutions for a wide variety of industry, agency, and corporate clients.
Deliver high quality support for clients to enable their success by providing timely permits along with appropriate compliance guidelines.<ul><li>
Prepare/oversee permit applications incorporating best management practices.</li><li>
Manage and develop technical staff to support permitting and compliance projects.</li><li>
Manage projects from inception through completion including proposal writing, budget tracking, and project closeout.</li><li>
Coordinate document revisions, including agency review comments, senior review comments, and author edits.</li><li>
Define project success criteria and disseminate to involved parties throughout project life cycle.</li><li>
Identify and manage project dependencies and critical path.</li><li>
Work closely with clients, regulators, and staff to determine timing and content for permit applications and ensure that projects are completed in compliance with applicable regulations or client expectations.</li><li>
Effective and professional communication with clients, team members, and regulators.</li></ul> 
 Skills, Knowledge and Abilities<ul><li>
Must be self-directed and motivated, and will rely on experience and judgment to plan and accomplish goals and objectives with limited to no oversight.</li><li>
Must be safety conscious at all times.</li><li>
Must have proven track record of meeting deadlines and executing projects according to agreed schedule.</li><li>
Must have working knowledge of commonly used concepts, practices, and procedures and be proficient in working with environmental permits and regulations.</li><li>
Detail oriented.</li><li>
Strong critical thinking skills.</li><li>
Computer knowledge and efficiency.</li><li>
Excellent verbal and written communication skills, including technical writing.</li><li>
Demonstrate proactive problem-solving skills.</li><li>
Ability to maintain organization in a changing environment.</li><li>
Exhibits initiative, responsibility and flexibility.</li><li>
Ability to work in a fast-paced environment and meet deadlines.</li><li>
Ability to work independently and in a team environment</li><li>
Must have demonstrated ability to build rapport and resolve complex natural resource issues.</li><li>
Candidates will possess the ability and interest to contribute to other environmental practice areas.</li></ul><div></div> 
Minimum Qualifications<ul><li>
Must possess a BS in Environmental Science, Chemistry, Biology, Ecology, or related field.</li><li>
Must have a minimum 10 years of experience in environmental, permitting, regulatory and compliance support.</li><li>
Must have a minimum of 10 years of Alaska Experience.</li><li>
Must have Oil and Gas, Mining, and Construction permitting experience.</li><li>
Must possess a valid driver&rsquo;s license.</li></ul><div></div><div> 
Working Conditions:</div><ul><li>
Full-time position with regular business hours; availability for over-time based on project timelines necessary.</li></ul><div></div><div> 
Fairweather is an equal-opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.</div><div>
This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employee(s) will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorized to give instructions or assignments.</div><div></div><div> 
A review of this position has excluded marginal functions of the position that are incidental to the performance of fundamental job duties. All duties and responsibilities are essential job functions and requirements and are subject to possible modification to reasonably accommodate individuals with disabilities. To perform this job successfully, the incumbent(s) will possess the skills, aptitudes, and abilities to perform each duty proficiently. Some requirements may exclude individuals who pose a direct threat or significant risk to the health or safety of themselves or others. The requirements listed in this document are the minimum levels of knowledge, skills, or abilities.</div><div></div><div> 
This job description is not an employment agreement or contract, implied or otherwise, other than an &ldquo;at will&rdquo; relationship. Management has the exclusive right to alter the scope of work within the framework of this job description at any time without prior notice.</div><div></div><div> 
PREFERENCE STATEMENT: Fairweather grants preference to qualified Doyon Shareholders first, and second to qualified shareholders of other Alaska Native corporations that grant a similar preference in all phases of employment and training, which include, but are not limited to hiring, promotion, layoff, transfer, and training.</div></div>

Regulatory and Non-Technical Risk Manager

Amgen

<div>HOW MIGHT YOU DEFY IMAGINATION? If you feel like you&rsquo;re part of something bigger, it&rsquo;s because you are. At Amgen, our shared mission&mdash;to serve patients&mdash;drives all that we do. It is key to our becoming one of the world&rsquo;s leading biotechnology companies. We are global collaborators who achieve together&mdash;researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It&rsquo;s time for a career you can be proud of. Join us.
Regulatory Affairs &quot;Labelling&quot; Manager| MEA
Scope:
Accountable for end‑to‑end execution of compliant, accurate, and timely local product labeling and packaging deliverables across assigned MEA markets. Ensures alignment with Global Core Labeling (GCL) and company labeling governance while incorporating local Health Authority requirements, language conventions, and lifecycle changes.
Key Responsibilities:<ul><li>
Own and execute local labeling activities for assigned products/country clusters (e.g., SmPC/PI, PIL/leaflet, carton/label text, IFU), ensuring content accuracy, completeness, and compliance.</li><li>
Translate global core updates into local implementation plans: perform impact assessments, draft/redline local texts, coordinate review/approval, and support submission strategy for labeling variations/line extensions.</li><li>
Act as local/regional **source text owner** for artwork creation: deliver &lsquo;right‑first‑time&rsquo; source texts and maintain traceability from CDS/CCDS/GCL changes to country label implementation.</li><li>
Coordinate packaging and artwork lifecycle activities (leaflet, label, blister, outer pack): initiate and manage updates, support shared pack/SKU strategy execution, and ensure supply‑readiness timelines are met.</li><li>
Manage translation workflows (including engaging translation agency systems): request translations, track readiness, and perform **100% translation review** for both content and format (as required for regional languages).</li><li>
Execute labeling/artwork review and approval tasks in designated systems (e.g., Veeva Vault, RIM/Regulatory Information Management, artwork management tools), maintaining version control and inspection‑ready documentation.</li><li>
Monitor and report operational metrics (e.g., right‑first‑time labels, cycle time, on‑time delivery) and drive corrective actions for recurring defects or bottlenecks.</li><li>
Support biosimilars labeling redaction/maintenance activities (as applicable to assigned portfolio).</li><li>
Support track‑and‑trace/serialization intelligence gathering and execution for assigned clusters; ensure packaging/labeling requirements are reflected in artworks and implementation plans.</li><li>
Draft, update, and/or support local SOPs and work instructions related to labeling management; ensure adherence to internal procedures and quality standards.</li><li>
Identify labeling and packaging risks (compliance, timelines, translations, artwork quality) and proactively propose mitigations; escalate issues per governance.</li></ul>
Qualifications:<ul><li>
Bachelor&rsquo;s degree in Pharmacy or related life sciences (required); advanced degree is an advantage.</li><li>
Typically 4&ndash;8+ years of Regulatory Affairs experience with strong hands‑on labeling and artwork/packaging lifecycle management.</li><li>
Current or previous experience within MNCs is a must.</li><li>
Knowledge of Middle East &amp; Africa regulatory requirements and practical experience coordinating multi‑country implementations.</li><li>
Language skills: English (required); French literacy strongly preferred; Arabic preferred when the role includes Arabic translation review responsibilities.</li><li>
Demonstrated proficiency working in regulated document and workflow systems (e.g., Veeva Vault, RIM tools) and in cross‑functional matrix environments.</li><li>
Skills/behaviors: detail orientation, planning/priority management, proactive risk management, clear written/oral communication, cultural awareness, and a quality mindset.</li></ul>
Thrive What You Can Expect Of Us As we work to develop treatments that take care of others, so we work to care for our teammates&rsquo; professional and personal growth and well-being. 
<ul><li>
Vast opportunities to learn and move up and across our global organization</li><li>
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act</li><li>
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits</li></ul>
Apply now for a career that defies imagination In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us. 
 
careers.amgen.com Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, gender, sexual orientation, gender identity, national origin, protected veteran status, or disability status.</div>

Regulatory Affairs "Labelling" Manager| MEA

Panda Retail Company – Savola Group

<div>
 
 
 Job Purpose:
 
 
 
 Lead and manage all activities related to supplier quality across Panda&rsquo;s supply base (local and international). Ensuring that suppliers consistently meet Panda&rsquo;s Quality, Food Safety, and Regulatory requirements from selection and approval through continuous performance monitoring and improvement
 
 
 
 
 
 
 Key Accountabilities:
 
 
 
 
 
 
 
 -Regulation Compliance:
 
 
 
 Manage Government Regulatory Compliance and control systems to ensure compliance to regulatory and legislation requirement (e.g. Municipality/ SASO/ SFDA etc.) and align guidelines with main stakeholders.
 
 
 
 
 
 Ensuring Regulatory Compliance and oversee control systems to prevent or deal with violations of legal and regulatory guidelines with main stakeholders from Commercial, Operations and Quality team.
 
 
 
 
 
 Collaborate with GR departments to monitor enforcement of standards and regulations and set a plan for timely compliance projects with the concerned department.
 
 
 
 
 
 Supports Panda&rsquo;s future projects to identify possible compliance risks and act as a governance role to ensure adherence to regulations throughout the projects.
 
 
 
 
 
 Keep abreast of regulatory developments within or outside of the company as well as evolving best practices in compliance control.
 
 
 
 
 
 Communicate all new circulations from regulatory authorities to the concerned departments and ensure compliance on time to avoid any violations of legal or regulatory guidelines.
 
 
 
 
 
 
 -Supplier Quality Management
 
 
 
 Lead and manage all activities related to supplier quality across Panda&rsquo;s supply base (local and international)
 
 
 
 
 
 Ensuring that suppliers consistently meet Panda&rsquo;s Quality, Food Safety, and Regulatory requirements from selection and approval through continuous performance monitoring and improvement.
 
 
 
 
 
 Drive the Supplier Qualification, Classification, and Performance Management Framework to secure safe, compliant, and high-quality products for customers.
 
 
 Non-conformity System.
 
 
 
 
 
 Handling the Non-conformity system to document, track, and escalate critical quality issues that may cause risk to the business by identifying the root-causes and addressing the right CAPAs.
 
 
 
 
 
 Manage non-conformity system and ensuing that Nonconformance management process functions effectively, and that all necessary guidance and training is available.
 
 
 
 
 
 Evaluates incoming food alerts and recalls and assess the impact to the business and/or its impact to determine the actions needed in response to internal or external notices
 
 
 Quality Projects Management
 
 
 
 
 
 Define and build a solid foundation of a Quality Assured Project Management that will be highly recognizable and relevant throughout the lifecycle of the project.
 
 
 
 
 
 Support assigned projects (Functional and Organizational Level) with the respective Department to ensure that projects are executed according to the agreed SLA.
 
 
 
 
 
 
 
 
 
 NPI Management
 
 
 
 Participate in New Product Introduction (NPI) and project team activity as required, to ensure that specifications are updated and reviewed, and that the product complies with Panda's standards.
 
 
 
 
 
 Oversee the development of Good Product Practices to ensure that products are safe and of the requisite quality for store availability.
 
 
 
 
 
 
 Key Competencies:
 
 
 
 -Supplier auditing and Lead auditor training.
 
 
 -Risk assessment and classification modelling.
 
 
 -Knowledge in Process and procedure analysis, development, and improvement and QMS.
 
 
 -Knowledge of local and international food safety standards (HACCP, ISO, AIB, BRC) and Saudi ------regulatory authorities&rsquo; standard requirements.
 
 
 -Process mapping and Improvement.
 
</div>

Quality Regulation Manager

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