regulatory affairs manager

Amgen

<div><div>Egypt - Cairo
<div>JOB ID: R-251623 LOCATION: Egypt - Cairo WORK LOCATION TYPE: Flex Commuter / Hybrid DATE POSTED: Jul. 29, 2026 CATEGORY: Regulatory
</div></div><div><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.
SENIOR ASSOCIATE REGULATORY AFFAIRS
WHAT YOU WILL DO
In this vital role you will assist in the local coordination and execution of regulatory submissions in compliance with Amgen corporate standards and national regulatory requirements, and Regulatory Affairs processes and deliverables for the ELI markets Egypt, Jordan, Iraq and Lebanon.<ul><li>
Ensure regulatory submissions are made on time and meet Amgen&rsquo;s corporate and local regulatory requirements</li><li>
Responsible for completion of regulatory files for submission. (Prepare/Receive files and submit them to regulatory authorities within the defined and agreed submission/approval dates) and according to guidelines and requirements</li><li>
Manufacturing site registration and license maintenance</li><li>
Responsible for coordinating with the International regulatory team to ensure right first-time dossiers are provided</li><li>
Coordinate and respond to the requests by authorities during the evaluation process and check the correct handling of deficiency letter within a specific timeframe in order not to delay MOH approvals</li><li>
Establish effective communication and continuous follow-up with the external agencies &amp; distributors to ensure timely submissions and approvals of all company&rsquo;s applications</li><li>
Monitoring of emerging guidelines and changes affecting business and communication to relevant internal customers</li><li>
Providing guidance on the approval processes to internal stakeholders within the region and providing regulatory input for launch planning</li><li>
Maintenance of all lifecycle activities/ Product renewal license details by accurately preparing filling submissions and approval within the preset global timelines -accountable for overall accuracy and compliance</li><li>
Ensure alignment of regulatory objectives with regional / global regulatory objectives and commercial plans</li><li>
Accountable for solving all supply issues related to regulatory activities.</li><li>
To provide regulatory intelligence</li><li>
Ensure compliance with company's SOPs and working practices for Good Regulatory Practice</li><li>
Management of documentation archiving and record keeping according to SOP and local legislation</li><li>
Contact for agency interactions for portfolio of products and coordinating and reviewing briefing documents and/or other submissions for meetings with Regulatory agencies</li><li>
Collate, distribute, exchange and archive regulatory information with colleagues across the business</li><li>
Participate in regulatory and affiliate process improvements initiatives</li><li>
Review promotion and non-promotion materials to ensure compliance with local license, company procedures and Code of Practice</li></ul>
BE PART OF OUR TEAM
Reporting to the Regulatory Affairs Manager for ELI, you would be joining a team of regulatory professionals passionate about delivering the best outcomes for our medicines to patients.
WHAT WE EXPECT OF YOU
We are all different, yet we all use our unique contributions to serve patients. What we seek in you as an experienced professional, are these qualifications and skills:<ul><li>
Pharmacy Bachelor&rsquo;s degree</li><li>
2-3 years of directly related experience in regulatory affairs (ELI markets)</li><li>
Knowledge and awareness of the relevant regulatory guidelines and legislation for ELI markets</li><li>
Strong communication skills both verbal and written</li><li>
Organizational skills &amp; developing regulatory project management skills</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>
 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></div></div>

Senior Associate Regulatory Affairs

Eli Lilly

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.
 
About the Role
 
As the Global Regulatory Lead (GRL), you will be the accountable decision maker for the development & execution of global regulatory strategies— from portfolio entry through end of life. You will build and lead the Global Regulatory Team, serve as the primary regulatory voice on the Global Brand Development (GBD) team, and own the relationship and interaction strategy with the US FDA.
 
Key Responsibilities
 Regulatory Strategy
 
<ul>
<li>Develop and execute innovative global regulatory strategies, owning the Regulatory Strategy Document (RSD) from Candidate Selection through end of lifecycle</li>
<li>Integrate competitive intelligence, health authority guidance, and product-specific regulatory advice to drive robust, forward-looking strategies</li>
<li>Lead regulatory representation on the GBD/global program team, shaping development plans and providing solutions to regulatory barriers</li>
<li>Ensure local affiliate regulatory plans align to global strategy and business priorities — spanning labeling, risk management, and issues management</li>
</ul>
US FDA Oversight
 
<ul>
<li>Oversee all US FDA submissions and agency interactions, including INDs, NDAs, and BLAs</li>
<li>Drive high-quality communications with FDA that clearly articulate Lilly's scientific position</li>
<li>Build and leverage productive relationships with FDA to support product registration goals</li>
</ul>
Team Leadership
 
<ul>
<li>Lead a cross-functional Global Regulatory Team inclusive of regional scientists, GRA-CMC, GRA-Devices, GRA-RD&E, and Global Labeling</li>
<li>Foster a culture of transparent communication, feedback, and continuous development</li>
<li>Communicate and share key information to enable seamless execution of global regulatory strategy and cross-functional shared learnings.</li>
<li>Represent GRA at stakeholder and governance meetings; mentor GRA personnel and may manage direct reports</li>
</ul>
External Engagement
 
<ul>
<li>Shape the external regulatory environment by building strategic relationships with key external stakeholders</li>
<li>Partner with Regulatory Product Communications and Global Marketing to advise on promotional strategy and review press/IR materials</li>
</ul>
Minimum Qualifications
 
<ul>
<li>Advanced scientific degree (i.e. PharmD, PhD) and 8+ years of experience in regulatory affairs and/or drug development</li>
</ul>
OR
 
<ul>
<li>Bachelor’s or Masters and 10+ years of experience in regulatory affairs and/or drug development</li>
</ul>
Additional Preferences
 
<ul>
<li>Deep knowledge of global regulatory procedures, evolving reform initiatives, and the integrated drug development process</li>
<li>Demonstrated experience with regulatory submissions and agency interactions across US, EU, China, and Japan</li>
<li>Direct experience in both clinical and CMC regulatory sciences</li>
<li>Strong leadership, negotiation, and stakeholder communication skills — including executive-level audiences</li>
<li>Proven ability to assess and manage risk in a highly regulated environment</li>
<li>Experience in the applicable therapeutic area</li>
</ul>
Additional Information
 
<ul>
<li>Travel expected: 10–15%</li>
</ul>
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
 
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
 
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).
 
Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is
 $169,500 - $248,600
 
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
 
#WeAreLilly

Global Regulatory Lead, Regulatory Strategy - Global Regulatory Affairs - Infectious Disease/Vaccine

Bupa

<div><h4 class="jobSectionHeader">Job Description</h4><div> 
o lead the completion of a program, project, event by coordinating and managing all the activities of an entire team. Also, to develop a plan of actions to accomplish specific initiatives and projects by working across departments to ensure the compliance, prompt actions &amp; punctuality of needed actions to result in a successful implementation of projects across Bupa Arabia (Operations) including regulatory / risk items. Also, to boost Bupa Arabia&rsquo;s relation with the regulators (SAMA &amp; CHI). 
Program /Portfolio Management: 
<ul><li>Manage project portfolios and ensure alignment with organizational priorities.</li></ul> 
<ul><li>Provide project management guidance and support to project managers and teams throughout the project lifecycle.</li></ul> 
<ul><li>Establish and maintain project management standards, methodologies, and best practices to ensure consistency and quality across projects.</li></ul> 
<ul><li>Oversee IT and APP Operational Projects, ensuring effective governance, reporting, and delivery.</li></ul> 
<ul><li>Oversee Non-IT Operational Projects, ensuring effective governance, reporting, and delivery.</li></ul> 
<ul><li>Manage operational risks and internal audit agendas until closure.</li></ul> 
<ul><li>Lead, mentor, and develop project managers and team members to enhance their skills and performance.</li></ul> 
<ul><li>Foster a collaborative and high-performance team environment</li></ul> 
Identify Business Opportunities and Highlight Risks: 
<ul><li>Conduct assessments to evaluate compliance with Operational requirements and identify areas for improvement including regulatory items.</li></ul> 
<ul><li>Conduct risk assessments and develop risk mitigation strategies to minimize compliance risks and ensure adherence to Operational guidelines.</li></ul> 
<ul><li>Conduct project reviews and lessons learned sessions to identify areas for improvement and promote continuous learning and development</li></ul> 
Stakeholders&rsquo; Engagement: 
<ul><li>Design and implement a new stakeholder engagement strategy which identifies the needs of key groups and the sponsor as he/she plays a vital role in ensuring those business needs are met.</li></ul> 
<ul><li>Select the best methodology in order to effectively communicate, collaborate, and interact with key people who have positive or negative influence, and may impact the success of the project.</li></ul> 
<ul><li>Monitoring and reporting on compliance metrics and key performance indicators to senior management and Operational bodies as required.</li></ul> 
<ul><li>Developing and implementing policies, procedures, and guidelines to ensure compliance with applicable regulations, laws, and standards.</li></ul> 
<ul><li>Monitoring and interpreting Operational changes and requirements in the healthcare industry.</li></ul> 
<ul><li>Oversee Operational projects including regulatory / risk items..</li></ul> 
<ul><li>Understand and optimize the customer journey (NPS).</li></ul> 
Operational Partnership : 
<ul><li>Collaborating with internal departments, such as legal, compliance, quality assurance, and operations, to assess and address Operational compliance issues.</li></ul> 
<ul><li>Providing guidance and training to employees on Operational requirements, ensuring understanding and adherence to compliance standards.</li></ul> 
<ul><li>Managing the process of responding to Operational inquiries; including gathering necessary information, preparing documentation, and coordinating responses</li></ul> 
Managing Executive-Directed Initiatives / Ad-Hoc Tasks. : 
<ul><li>Quickly assess and prioritize tasks assigned by management, ensuring timely and efficient completion.</li></ul> 
<ul><li>Collaborate with various departments to gather necessary information and resources to address ad-hoc tasks effectively.</li></ul> 
<ul><li>Keep management informed of the progress and status of ad-hoc tasks, ensuring transparency and accountability.</li></ul> 
<ul><li>Lead, mentor, and develop project managers and team members to enhance their skills and performance.</li></ul> 

</div><h4 class="jobSectionHeader">Skills</h4>
<div><ul><li>Working experience in Microsoft Office, PowerPoint, Excel, Word, Outlook, Teams &amp; Visio.</li>
<li>Intermediate to advanced skill in using Power BI, SAS and Congos.</li>
<li>Strong verbal &amp; written communications Skills (English &amp; Arabic).</li>
<li>Ability to build, develop and maintain positive internal &amp; external relationships.</li>
<li>Excellent negotiation skills and ability to take initiatives.</li>
<li>Manage deadlines and push the team to ensure timeliness.</li>
<li>Leadership qualities, such as motivation techniques and conflict-management</li>
<li>Developing employee skills and performance through coaching</li>
⁠<li>Experienced &amp; familiar with corporate, Operational &amp; compliance work environments</li></ul></div></div>

<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.
 
 
 
 SENIOR ASSOCIATE REGULATORY AFFAIRS
 
 
 
 
 What You Will Do
 
 
 
 In this vital role you will assist in the local coordination and execution of regulatory submissions in compliance with Amgen corporate standards and national regulatory requirements, and Regulatory Affairs processes and deliverables for the ELI markets Egypt, Jordan, Iraq and Lebanon.
 
 
 <ul>
 <li>
 Ensure regulatory submissions are made on time and meet Amgen&rsquo;s corporate and local regulatory requirements
 </li>
 <li>
 Responsible for completion of regulatory files for submission. (Prepare/Receive files and submit them to regulatory authorities within the defined and agreed submission/approval dates) and according to guidelines and requirements
 </li>
 <li>
 Manufacturing site registration and license maintenance
 </li>
 <li>
 Responsible for coordinating with the International regulatory team to ensure right first-time dossiers are provided
 </li>
 <li>
 Coordinate and respond to the requests by authorities during the evaluation process and check the correct handling of deficiency letter within a specific timeframe in order not to delay MOH approvals
 </li>
 <li>
 Establish effective communication and continuous follow-up with the external agencies &amp; distributors to ensure timely submissions and approvals of all company&rsquo;s applications
 </li>
 <li>
 Monitoring of emerging guidelines and changes affecting business and communication to relevant internal customers
 </li>
 <li>
 Providing guidance on the approval processes to internal stakeholders within the region and providing regulatory input for launch planning
 </li>
 <li>
 Maintenance of all lifecycle activities/ Product renewal license details by accurately preparing filling submissions and approval within the preset global timelines -accountable for overall accuracy and compliance
 </li>
 <li>
 Ensure alignment of regulatory objectives with regional / global regulatory objectives and commercial plans
 </li>
 <li>
 Accountable for solving all supply issues related to regulatory activities.
 </li>
 <li>
 To provide regulatory intelligence
 </li>
 <li>
 Ensure compliance with company's SOPs and working practices for Good Regulatory Practice
 </li>
 <li>
 Management of documentation archiving and record keeping according to SOP and local legislation
 </li>
 <li>
 Contact for agency interactions for portfolio of products and coordinating and reviewing briefing documents and/or other submissions for meetings with Regulatory agencies
 </li>
 <li>
 Collate, distribute, exchange and archive regulatory information with colleagues across the business
 </li>
 <li>
 Participate in regulatory and affiliate process improvements initiatives
 </li>
 <li>
 Review promotion and non-promotion materials to ensure compliance with local license, company procedures and Code of Practice
 
 
 </li>
 </ul>
 
 BE PART OF OUR TEAM
 
 
 
 Reporting to the Regulatory Affairs Manager for ELI, you would be joining a team of regulatory professionals passionate about delivering the best outcomes for our medicines to patients.
 
 
 
 What We Expect Of You
 
 
 
 We are all different, yet we all use our unique contributions to serve patients. What we seek in you as an experienced professional, are these qualifications and skills:
 
 
 <ul>
 <li>
 Pharmacy Bachelor&rsquo;s degree
 </li>
 <li>
 2-3 years of directly related experience in regulatory affairs (ELI markets)
 </li>
 <li>
 Knowledge and awareness of the relevant regulatory guidelines and legislation for ELI markets
 </li>
 <li>
 Strong communication skills both verbal and written
 </li>
 <li>
 Organizational skills &amp; developing regulatory project management skills
 
 
 </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>

CCL Pharmaceuticals

<div>
 
 
 Who We Are
 
 
 
 
 
 
 CCL Pharmaceuticals is a global life sciences company committed to improving access to trusted healthcare. With a presence in more than 20 countries and six decades of impact, we work to enable Healthy, Happy Lives through science-backed solutions.
 
 
 Our portfolio spans diabetes, cardiovascular, neurology, psychiatry, urology, oncology, immunology, biosimilars, cough and cold, vitamins, minerals, and supplements segments, to name a few. Across all markets, over 3,000 people combine scientific expertise, local insight, and a shared purpose to enhance how individuals live, heal, and care for themselves.
 
 
 Joining CCL Pharmaceuticals means stepping into a collaborative, mission-driven environment where your growth matters as much as your contribution. We enable you to learn, lead, and innovate through every stage of your journey, because the impact we make in healthcare begins with how you Grow with CCL.
 
 
 
 
 
 
 What You'll Do
 
 
 
 In this role, you will lead the planning, execution, and continuous improvement of qualification and validation activities across manufacturing, utilities, facilities, equipment, cleaning processes, analytical methods, and production processes in accordance with the Validation Master Plan (VMP) and global regulatory requirements. You will oversee the development and maintenance the Validation Master Plan, review validation protocols and reports, coordinate qualification activities with Engineering and Manufacturing teams, administer Product Quality Reviews (PQRs), support regulatory inspections and new product registrations, and drive continuous improvements that strengthen compliance, inspection readiness, and operational excellence.
 
 
 
 
 
 
 You Are Good At
 
 
 <ul>
 <li>
 Leading qualification and validation programs across manufacturing operations.
 </li>
 <li>
 Developing and executing Validation Master Plans (VMP).
 </li>
 <li>
 Reviewing validation protocols, reports, and technical documentation with accuracy and attention to detail.
 </li>
 <li>
 Managing cross-functional validation projects and balancing competing priorities.
 </li>
 <li>
 Administering Product Quality Reviews (PQRs) and driving timely follow-up actions.
 </li>
 <li>
 Interpreting GMP, PIC/S, and regulatory requirements to ensure compliant validation practices.
 </li>
 <li>
 Supporting regulatory inspections and validation documentation for product registrations.
 </li>
 <li>
 Building collaborative relationships across Manufacturing, Engineering, Quality Control, and Regulatory Affairs functions.
 </li>
 <li>
 Applying analytical thinking and structured problem-solving to quality and validation challenges.
 </li>
 <li>
 Driving continuous improvement across quality and validation systems.
 </li>
 </ul>
 
 
 
 
 
 What You'll Bring
 
 
 <ul>
 <li>
 Pharm.D, or Master's in Chemistry from and HEC recognized university.
 </li>
 <li>
 7-8 years of experience in Qualification, Validation, or Quality Assurance within a pharmaceutical manufacturing organization.
 </li>
 <li>
 Strong expertise in Validation Master Planning, Process Validation, Cleaning Validation, Analytical Method Validation, Equipment Qualification, Utility Qualification, and Facility Qualification.
 </li>
 <li>
 Sound knowledge of Product Quality Reviews (PQR), cGMP, PIC/S, and international regulatory requirements.
 </li>
 <li>
 Experience supporting regulatory inspections and validation documentation for new product registrations.
 </li>
 <li>
 Proficiency in Microsoft Office and documentation management systems.
 </li>
 <li>
 Strong analytical, leadership, presentation, communication, and stakeholder management skills.
 </li>
 </ul>
 
 
 
 
 
 Who You'll Work With
 
 
 
 This role reports directly to the General Manager Quality Assurance and works closely with teams across Quality Assurance, Manufacturing, Engineering, Quality Control, Regulatory Affairs, Supply Chain, and other operational functions to strengthen validation excellence, regulatory compliance, and quality systems across the organization.
 
 
 
 
 
 The culture you'll experience is shaped by three principles:
 
 <ul>
 <li>
 Transparency in communication, goals, and decision-making.
 </li>
 <li>
 Inclusion in how people are developed, supported, and empowered.
 </li>
 <li>
 Performance-driven mindset that links quality excellence to business outcomes.
 </li>
 </ul>
 
 Our values guide how we work every day:
 
 <ul>
 <li>
 Integrity First &ndash; Doing the right thing, consistently.
 </li>
 <li>
 Collaborate to Win &ndash; Building success together.
 </li>
 <li>
 Passion to Grow &ndash; Continuous learning and development.
 </li>
 <li>
 Innovation to Excel &ndash; Improving impact through better ideas.
 </li>
 </ul>
 
 
 
 
 
 What We Offer
 
 
 
 Opportunity to lead qualification and validation initiatives within a globally growing pharmaceutical organization.
 
 
 Exposure to international regulatory standards, validation practices, and quality systems.
 
 
 Cross-functional leadership opportunities across Manufacturing, Engineering, Quality Control, and Regulatory Affairs.
 
 
 A collaborative workplace focused on innovation, compliance, and continuous improvement.
 
 
 
 
 
 
 Important Notice
 
 
 
 CCL Pharmaceuticals is an equal opportunity employer. All applicants are considered based on merit, qualifications, and organizational need. We are committed to fostering an inclusive environment that respects diverse backgrounds, perspectives, and experiences.
 
 
 
 
 
 For more information about this opportunity and to apply, please visit our website: Sign In - Applicant Portal
 
</div>

Manager Quality Assurance

North Carolina Real Estate Commission

<div>The North Carolina Real Estate Commission is seeking an experienced legal professional to serve as Assistant Director of Regulatory Affairs.
An employee in this class serves as the chief assistant to the Director of Regulatory Affairs, assisting with supervision and management responsibilities of the division, and serving in the absence of the Director. The position oversees administrative and nonattorney consumer and information staff, provides training for legal and nonlegal personnel, and performs attorney duties involving complex disciplinary and civil litigation cases. The employee also serves as an internal legal resource for other departments, providing guidance to staff attorneys and managing the most complex cases before the Commission. Additional responsibilities include contributing to the development of long and shortterm priorities, policies, and performance standards; assisting with personnel management; drafting proposed legislation; and preparing legal articles. The role requires strong independent judgment, initiative, public interaction skills, extensive knowledge of state real estate laws and related statutes, and proven leadership and managerial abilities. Work is performed under the general supervision of the Director of Regulatory Affairs and evaluated through discussions, results, and feedback from management, the Commission, licensees, and the public. Desirable Experience
Considerable years of progressively responsible professional legal experience, including courtroom litigation and some supervisory experience.
Necessary Special Qualification
Law degree from a recognized school of law.Licensed to practice in the State of North Carolina.Successful completion of State Bar required hours of annual CLE credits. Required Application MaterialsApplicants must submit a writing sample as part of the application.</div>

Assistant Director of Regulatory Affairs

University of Southern California

<div>Job ID REQ20178332 Category Nursing</div>
 <div>Clinical Research Regulatory Specialist - Operations
The University of Southern California (USC), founded in 1880, is one of the world&rsquo;s leading private research universities and the largest private employer in the City of Los Angeles. As a member of the Trojan Family, you will join a vibrant community of faculty, staff, students, and researchers dedicated to advancing knowledge, innovation, and excellence in education, research, and patient care.
Position Summary:
Reporting to the Assistant Director of Clinical Research Operations, the Regulatory Affairs Specialist is responsible for overseeing and managing the regulatory aspects of clinical research studies conducted through the Clinical Trials Office. This role independently manages complex, multi-phase clinical research protocols from study start-up through closeout, ensuring compliance with all applicable federal, state, local, sponsor, and institutional regulations governing human subjects research.
The Regulatory Affairs Specialist serves as the primary regulatory resource for non-cancer clinical trials and is responsible for coordinating, preparing, and maintaining regulatory documentation for industry-sponsored, federally funded, and investigator-initiated studies. The incumbent will lead regulatory-related study meetings, maintain investigator site files, ensure the timely collection and maintenance of essential documents, and support study teams in meeting all regulatory requirements throughout the lifecycle of a clinical trial.
This position plays a key role in developing and implementing processes that promote regulatory compliance, data integrity, and adherence to Good Clinical Practice (GCP), institutional standard operating procedures (SOPs), and University policies.
Key Responsibilities:
<ul><li>Manage all regulatory activities for assigned clinical research studies from study initiation through closeout.
</li><li>Prepare, submit, and track regulatory submissions, including Initial Applications, Amendments, Continuing Reviews, and Reportable Events to the Institutional Review Board (IRB), Food and Drug Administration (FDA), sponsors, and other regulatory agencies as required.
</li><li>Ensure timely reporting of regulatory submissions, adverse events, protocol deviations, and other reportable events in accordance with applicable regulations and study requirements.
</li><li>Maintain accurate and audit-ready investigator site files and essential regulatory documentation.
</li><li>Collaborate with Principal Investigators, study coordinators, sponsors, and research staff to ensure ongoing regulatory compliance.
</li><li>Serve as a liaison with regulatory and compliance entities, including the IRB, FDA, sponsor representatives, monitors, and external agencies.
</li><li>Participate in and lead study-related regulatory meetings, providing guidance on regulatory requirements and compliance considerations.
</li><li>Maintain accurate study information within the Clinical Trial Management System (OnCore) and electronic regulatory system (Florence).
</li><li>Develop and implement workflows and best practices that enhance regulatory oversight, documentation quality, and study compliance.
</li><li>Support audit and inspection readiness activities and assist with responses to regulatory findings, when necessary.
</li><li>Ensure adherence to Good Clinical Practice (GCP), institutional policies, sponsor requirements, and all applicable regulatory standards.
</li></ul>Required Qualifications:
<ul><li>Demonstrated experience preparing and submitting IRB applications, including Initial Reviews, Amendments, Continuing Reviews, and Reportable Events.
</li><li>Strong knowledge of clinical research regulatory processes and documentation requirements.
</li><li>Excellent interpersonal skills with the ability to build and maintain effective working relationships across the Health System.
</li><li>Exceptional organizational skills with meticulous attention to detail.
</li><li>Ability to effectively manage multiple priorities, adapt to changing demands, and meet critical deadlines in a fast-paced environment.
</li><li>Strong analytical and problem-solving skills, with the ability to identify issues, develop solutions, and implement corrective actions independently.
</li><li>Proven ability to exercise sound judgment, discretion, and independent decision-making.
</li><li>Excellent written and verbal communication skills.
</li><li>Ability to research, evaluate, interpret, and synthesize complex information and prepare clear, concise reports and correspondence.
</li><li>Strong customer service orientation and commitment to responsive stakeholder support.
</li><li>High level of professionalism, integrity, and discretion in handling confidential information.
</li><li>Ability to work independently while contributing effectively as part of a collaborative team.
</li><li>Proficiency with Microsoft Office Suite (Outlook, Word, Excel, PowerPoint, Teams) and virtual meeting platforms such as Zoom.
</li><li>Demonstrated ability to establish and maintain accurate files, records, and regulatory documentation.
</li><li>Experience working effectively with individuals from diverse cultural, educational, and professional backgrounds.
</li></ul>Minimum Qualifications:
<ul><li>High school diploma or equivalent combined with sufficient experience and demonstrated competencies required to successfully perform the duties of the position.
</li><li>Bachelor&rsquo;s degree preferred.
</li><li>Minimum of 3-5 years of clinical research regulatory experience as a Regulatory Affairs Coordinator (RAC) or Assistant Regulatory Affairs Coordinator, or an equivalent combination of education and experience.
</li></ul>Preferred Qualifications:
<ul><li>Working knowledge of federal, state, local, and institutional regulations governing clinical research and human subject protections.
</li><li>Experience supporting a variety of clinical trial types, including industry-sponsored, federally funded, cooperative group, and investigator-initiated studies.
</li><li>Research certification such as ACRP, SoCRA, CCRP, or equivalent.
</li><li>Current CITI Human Subjects Research certification.
</li><li>Demonstrated expertise in clinical research regulatory compliance, including Phase I-IV drug studies and medical device trials.
</li><li>Comprehensive understanding of IRB processes, FDA regulations, and regulatory requirements throughout the clinical trial lifecycle.
</li><li>Experience with Clinical Trial Management Systems (OnCore) and electronic regulatory systems (Florence) preferred.
</li></ul>Follows established USC and department policies, procedures, objectives, performance improvement, attendance, safety, environmental, and infection control guidelines, including adherence to the workplace Code of Conduct and Compliance Plan.
This position is remote. Work hours and remote days may be subject to change depending on business needs.
The annual range for this position is $75,968.95 - $ 101,364.43. When extending an offer of employment, the University of Southern California considers factors such as (but not limited to) the scope and responsibilities of the position, the candidate's work experience, education/training, key skills, internal peer equity, federal, state and local laws, contractual stipulations, grant funding, as well as external market and organizational considerations 
 
Minimum Education: Bachelor's degree Addtional Education Requirements Combined experience/education as substitute for minimum education Minimum Experience: 2 years Addtional Experience Requirements Combined experience/education as substitute for minimum work experience Minimum Skills: Experience in clinical research compliance, regulatory research and/or operations in the academic or private sector. Experience with submissions to the Institutional Review Board and/or the Federal Drug Administration for Investigational Drugs and Devices (IND/IDE). Knowledgeable of Informational Conference on Harmonization-Good Clinical Practice (ICHGCP), Department of Health and Human Services (DHHS), Office of Human Research Protections (OHRP) and FDA regulations and procedures. Ability to evaluate the risks and benefits of different solutions, and proven problem-solving and decision-making skills to uncover causes of problems. Exemplary organization skills and attention to detail. Proven ability to interpret, analyze, and apply pertinent policies, procedures, regulations, and requirements. Deft interpersonal and diplomatic skills for communicating tactfully with all levels of staff and varied individuals and groups. Demonstrated experience developing communication plans, instructional materials and related content. Experience with office management communication software/tools (e.g., Google suite, Slack, Skype). Preferred Education: Bachelor's degree Preferred Experience: 3 years in clinical research compliance, regulatory research and/or operations in the academic or private sector Preferred Skills: Extensive experience in compliance oversight, coordination, monitoring, and/or auditing of clinical research studies and trials. Advanced knowledge of regulations governing human research.
<div>Job ID REQ20178332 Posted Date 07/30/2026</div></div>

Clinical Research Regulatory Specialist

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