regulatory affairs manager

Revolut

<div>About Revolut
People deserve more from their money. More visibility, more control, and more freedom. Since 2015, Revolut has been on a mission to deliver just that. Our powerhouse of products &mdash; including spending, saving, investing, exchanging, travelling, and more &mdash; help our 70+ million customers get more from their money every day.
As we continue our lightning-fast growth,&zwnj; 2 things are essential to our success: our people and our culture. In recognition of our outstanding employee experience, we've been certified as a Great Place to Work&trade;. So far, we have 13,000+ people working around the world, from our offices and remotely, to help us achieve our mission. And we're looking for more brilliant people. People who love building great products, redefining success, and turning the complexity of a chaotic world into the simplicity of a beautiful solution.
About the role
The Regulatory Affairs team builds transparent relationships with regulators to keep Revolut moving forward with confidence. They stay ahead of regulatory change, provide timely responses to enquiries, and work across the business to ensure compliance is always in step with innovation.
We're looking for a Senior Regulatory Affairs Manager to manage regulatory engagement across the UAE.
You'll ensure our relationships with regulators are transparent by shaping the local regulatory engagement strategy, managing regulatory communications, and providing regulatory advice to leadership.
Up to shape what's next in finance? Let&rsquo;s get in touch.
What you&rsquo;ll be doing<ul><li>
Leading local regulatory engagement, ensuring interactions are transparent, professional, and consistent with Revolut&rsquo;s global standards</li><li>
Anticipating regulatory change and expectations, translating these into actionable strategies</li><li>
Ensuring regulatory commitments and remediation actions are tracked to completion</li><li>
Supporting the end-to-end management of regulatory inspections and audits</li><li>
Partnering with Product Owners and the Legal team to launch new features within the UAE's regulatory framework, and proactively engaging with regulators to test innovative solutions</li><li>
Preparing high-quality management information and briefing materials, ensuring regulatory matters are escalated when required</li><li>
Providing strategic regulatory advice and counsel to senior management and the group</li><li>
Building processes and documentation in a scalable and sustainable way</li><li>
Being a champion for conduct and compliance across the business</li></ul>
What you'll need<ul><li>
7+ years of experience in regulatory affairs, compliance, or risk management within a top-tier financial institution, fintech, or a regulatory body</li><li>
An existing professional network within the regulatory environment in the UAE</li><li>
Familiarity with key regulatory compliance regimes</li><li>
An understanding of the payments systems and markets with a focus on technology and mobile applications</li><li>
Excellent stakeholder management, communication, project management, and negotiation skills</li><li>
Knowledge of best practice in regional financial institutions regulations</li><li>
Problem-solving and decision-making skills to analyse complex information and identify the key issue/action to drive resolutions</li><li>
Experience coaching and inspiring people</li></ul>
Nice to have<ul><li>
A solid academic background from a top-tier university, including a degree in law, public policy, business administration, or finance</li><li>
An advanced qualification (LLB/LLM, CA, CS, CFA, etc.)</li></ul>
Building a global financial super app isn&rsquo;t enough. Our Revoluters are a priority, and that&rsquo;s why in 2021 we launched our inaugural D&amp;I Framework, designed to help us thrive and grow everyday. We're not just doing this because it's the right thing to do. We&rsquo;re doing it because we know that seeking out diverse talent and creating an inclusive workplace is the way to create exceptional, innovative products and services for our customers. That&rsquo;s why we encourage applications from people with diverse backgrounds and experiences to join this multicultural, hard-working team.
Important notice for candidates:
Job scams are on the rise. Please keep these guidelines in mind when applying for any open roles.<ul><li>Only apply through official Revolut channels. We don&rsquo;t use any third-party services or platforms for our recruitment.</li><li>Always double-check the emails you receive. Make sure all communications are being done through official Revolut emails, with an @revolut.com domain.</li></ul>
We won't ask for payment or personal financial information during the hiring process. If anyone does ask you for this, it&rsquo;s a scam. Report it immediately.
By submitting this application, I confirm that all the information given by me in this application for employment and any additional documents attached hereto are true to the best of my knowledge and that I have not wilfully suppressed any material fact. I confirm I have disclosed if applicable any previous employment with Revolut. I accept that if any of the information given by me in this application is in any way false or incorrect, my application may be rejected, any offer of employment may be withdrawn or my employment with Revolut may be terminated summarily or I may be dismissed. By submitting this application, I agree that my personal data will be processed in accordance with Revolut's Candidate Privacy Notice</div>

Regulatory Affairs Manager

Astellas Pharma

<div>
 
 Description
 
 
 
 
 Regulatory Affairs Manager - Levant
 
 
 
 
 About Astellas
 
 
 
 Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at Astellas.com
 
 
 
 Are you driven to make a real difference in the lives of patients?
 
 
 
 We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact.
 
 
 
 Location and Working Environment
 
 
 
 This position is hybrid and will require you to be onsite 2 days per week/month/quarter in ISTANBUL, TURKEY office
 
 
 Astellas&rsquo; Responsible Flexibility Guidelines Statement- At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas&rsquo; Responsible Flexibility Guidelines.
 
 
 
 Purpose &amp; Scope
 
 
 
 <ul>
 <li>
 As the Regulatory Affairs Manager - Levant, you will be reporting directly to the Sub-Regional Lead, Turkey Middle East Africa (TMEA) and be responsible to arrange the provision of regulatory expertise and execution of regulatory strategy &amp; activities for new Marketing Authorizations (MAs) and Life Cycle Management of MAs in the territory.
 </li>
 <li>
 This is an individual contributor position, full time, permanent position.
 
 
 </li>
 </ul>
 
 Role And Responsibilities
 
 
 
 <ul>
 <li>
 Develop national regulatory submission strategy and planning for new MAA and Life Cycle management activities. Advise on optimal regulatory pathway &amp; timelines, dossier content including CMC, Clinical and labelling, EAP/CDx.
 </li>
 <li>
 Initiate, review and approve Product information (SmPC/aPI/PIL/aRMM) &amp; artworks
 </li>
 <li>
 Ensure timely preparation, submission to the HA and follow up of regulatory applications including preparation of regional/local specific documents and other tasks (eg translations).
 </li>
 <li>
 Ensure regulatory compliance &amp; reputation. Develop and maintain professional relationships with relevant external contacts including the Health Authority and Trade Associations
 </li>
 <li>
 Review/approve promotional materials with an in-depth understanding of code
 
 
 </li>
 </ul>
 
 Required Qualifications
 
 
 
 <ul>
 <li>
 Substantial experience within a similar Regulatory Affairs role ideally with a global pharma organization.
 </li>
 <li>
 Experience working with distributor markets &amp; business partners across the Levant and Gulf region would be highly preferred.
 </li>
 <li>
 Knowledge of Regulatory landscape and procedures within the country/region
 </li>
 <li>
 Knowledge of the Regulatory compliance
 </li>
 <li>
 Strong communication skills with the ability to work through change management
 </li>
 <li>
 BA/BS Degree in Pharmacy, Medical or other Life Science, or equivalent
 
 
 </li>
 </ul>
 
 Preferred Qualifications
 
 
 
 <ul>
 <li>
 Good communication, influential, planning and problem-solving skills, along with the ability to build and manage close relationships with all relevant stakeholders.
 
 
 </li>
 </ul>
 
 What awaits you at Astellas?
 
 
 
 <ul>
 <li>
 Global collaboration: Become part of a connected global business of like-minded life science leaders, all dedicated to improving patients' lives worldwide.
 </li>
 <li>
 Real-world patient impact: Contribute to transformative therapies that reach patients around the world, knowing your work makes a difference every day.
 </li>
 <li>
 Relentless Innovation: Join a company at the forefront of scientific breakthroughs, where you'll have the opportunity to shape the future of healthcare.
 </li>
 <li>
 A Culture of Growth: Chart your own course within a supportive environment that values your contributions, champions your development, and empowers you to pursue your passions.
 
 
 </li>
 </ul>
 
 Our Organizational Values and Behaviors
 
 
 
 <ul>
 <li>
 Impact
 </li>
 <li>
 Innovation
 </li>
 <li>
 Integrity
 </li>
 <li>
 One Astellas
 </li>
 <li>
 Accountability
 </li>
 <li>
 Courage
 </li>
 <li>
 Sense of Urgency
 </li>
 <li>
 Outcome Focus
 
 
 </li>
 </ul>
 
 Benefits
 
 
 
 Careers | Astellas
 
 
 We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
 
 
 Beware of recruitment scams impersonating Astellas recruiters or representatives. Authentic communication will only originate from an official Astellas LinkedIn profile or a verified company email address. If you encounter a fake profile or anything suspicious, report it promptly to LinkedIn's support team through LinkedIn Help.
 
 
 # LI-Istanbul
 
 
</div>

Regulatory Affairs Manager - Levant

Bristol Myers Squibb

<div>Working with Us 
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. 
 
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us . 
 
Expected Areas of Competence
 
<ul><li>Develop and lead Global and US Regulatory activities for a Development Team (s), leveraging primarily external resources for operation activities, and internal resources for strategic and HA engagement.</li><li>Collaborate and influence internal BMS expertise and external regulatory resources to assure regulatory issues are addressed in development plans</li><li>Provide leadership to resolve critical regulatory project issues, bring the appropriate regulatory experts together as needed</li><li>Establish sound regulatory advice/position on key development issues, and communicate same to DTL and other team stakeholders</li><li>Develop registration strategy for a product, and translate that into operational deliverables for execution by external and specific internal resources</li><li>Develop alternative plans for achieving regulatory objectives with associated risks and mitigation strategies</li><li>Provide strategic regulatory input to key development documents and study reports, including Clinical protocols, clinical reports/summary documents, nonclinical reports/summary documents Nonclinical and clinical summary documents, Analysis Plans and DMC Charters</li><li>Provide strategic regulatory input on the target product profile, CCDS, and country-specific label</li><li>Create an asset specific Global and US HA interactions strategy, integrating regional/local objectives and strategies and lead effective interactions with HA globally, partner with regional / local liaisons to execute interactions</li><li>Formulate US regulatory strategy and filings</li><li>Formulate integrated global submission plan for simultaneous filings and take accountability for translating that into operational plans to be delivered by external vendors</li><li>Approval of regulatory documents</li><li>Ensure documents and regulatory dossier are compiled according to appropriate standard and guidelines</li></ul> 
Behaviors
 
<ul><li>Translates broad strategies into specific objectives and action plans that can be effectively executed by external partners.</li><li>Sets challenging, but regulatory achievable objectives, comfortable taking risk in the regulatory setting</li><li>Generates alternative regulatory strategies and plans, and assesses benefits and risks.</li><li>Develops contingency plans and meets challenges necessary to execute business and action plans. Ensures these plans are feasible using external resources.</li><li>Creates a unified and seamless team using both internal and external resources to execute regulatory strategy</li><li>Communicates opinions, facts and thoughts with clarity, transparency and honesty</li><li>Seeks multiple perspectives and listens openly to others' points of views.</li><li>Enables and demonstrates the courage to speak up on issues and risks as well as on the good news.</li><li>Demonstrates ownership of results within (and beyond) area of responsibility.</li><li>Sets clear and high expectations and holds self and others accountable for decisions and results achieved.</li><li>Develops and applies unique ideas and new methods to achieve higher performance and excellence.</li><li>Works across organizational, functional and geographic boundaries to achieve company goals.</li><li>Creates an environment that encourages continuous improvement, innovation and appropriate risk taking.</li><li>Demonstrates resilience and perseverance.</li></ul> 

Degree / Experience Requirements
 
 
<ul><li>Solid scientific background, Ph.D., M.D., PharmD, MS, or BS
</li></ul> 
<ul><li>Significant experience in regulatory affairs (e.g. &gt; 4-7 years)
</li></ul> 
Qualifications
 
<ul><li>Proven success in delivering effective global regulatory strategies in coordination with clinical plans and marketing objectives leading to successful registration.</li><li>Excellent in communicating regulatory strategy, issues, and risks in written and verbal format</li><li>Experience leading cross functional matrix teams</li><li>Demonstrated ability to break down complex, scientific issue and communicating regulatory implications</li><li>Proven success in negotiating regulatory objectives with HA
</li></ul> 
If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
 
 
Compensation Overview: 
 
Cambridge Crossing: $240,940 - $291,964
 
Madison - Giralda - NJ - US: $215,130 - $260,683 
 
The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.
 
 
Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/.
 
 
Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include:
<ul><li>Health Coverage: Medical, pharmacy, dental, and vision care.</li><li>
Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
</li><li>Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
</li></ul>Work-life benefits include:
 
 
Paid Time Off
<ul><li>US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)
</li><li>Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays
</li></ul>Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.
 
 
All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown. 
 
<ul><li>Eligibility Disclosure: T he summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program.
</li></ul> 
Uniquely Interesting Work, Life-changing Careers 
With a single vision as inspiring as Transforming patients' lives through science&trade; , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. 
 
On-site Protocol 
 
BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
 
 
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
 
 
Supporting People with Disabilities 
 
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement.
 
 
Candidate Rights 
 
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
 
 
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/
 
 
Data Protection 
 
We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection . 
 
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. 
 
If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at TAEnablement@bms.com . Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley.
 
 
R1600351 : Director, Regulatory Strategist, Global Regulatory Affairs</div>

Director, Regulatory Strategist, Global Regulatory Affairs

Padagis LLC

<div>Padagis US LLC is seeking an experienced and dynamic Director or Associate Director of Regulatory Affairs that will be responsible for overseeing regulatory strategies, submission requitements and writing for pharmaceutical products targeted for the U.S. market. Majority of the submissions are ANDAs for generic products in a variety of dosage forms such as complex oral solids, injectables, transdermal, and sterile ointments. In this pivotal role, you will work cross-functionally with internal teams and external stakeholders to ensure regulatory compliance, provide consultation on regulatory aspects during the development phase, ensure all activities are planned and executed for a successful submission.

This position plays a critical role in guiding products through the development pipeline, securing FDA approval, and establishing a strong foundation for market entry.

Note: This is a remote workplace eligible position for candidates residing in the United States, with preference given to candidates in the Minneapolis-St. Paul, Minnesota area.

Job duties:
<ul>
<li>Regulatory Strategy Development:
<ul><li>Develop and implement comprehensive regulatory strategies to support the development phase according to the current FDA guidances and recent trends.</li>
<li>Provide regulatory leadership during all phases of product development, including preclinical, clinical, and manufacturing stages, ensuring alignment with FDA standards and guidelines.</li>
<li>Assess and mitigate regulatory risks, ensuring anticipated challenges are addressed proactively.</li>
<li>Regulatory Submissions and Approvals: Oversee the preparation, submission, and management of high-quality regulatory documentation, including INDs, NDAs, ANDAs, and amendments to the FDA.</li>
<li>Plan and execute submission timelines to ensure timely filings and approvals within project deadlines.</li>
<li>Collaborate with cross-functional teams, including R&amp;D , Clinical Affairs, Quality, and Manufacturing, to compile, review, and finalize submission packages.</li>
<li>Communication and Liaison with FDA: Serve as the primary point of contact with the FDA for assigned development programs, ensuring a professional and transparent relationship. Coordinate and facilitate meetings with the FDA, including Pre-IND, End-of-Phase, and Pre-NDA meetings, PDEV -meeting for ANDAs and Control Correspondences to ensure alignment with regulatory expectations.</li>
<li>Respond to FDA queries and requests in a timely and accurate manner to maintain project momentum.</li>
<li>Collaborate with cross-functional teams to ensure regulatory compliance in launch preparation, advertising, promotional materials, and post-marketing surveillance.</li>
<li>Support the coordination of Risk Evaluation and Mitigation Strategies (REMS) and ensure compliance with post-approval regulatory commitments.</li>
</ul></li></ul><ul><li>Regulatory Affairs Expertise and Leadership:
<ul><li>Stay current with evolving FDA regulations, guidances, and industry trends to ensure compliance and improve internal regulatory processes.</li>
<li>Provide mentorship, training, and guidance to junior regulatory staff and help cultivate a high-performing regulatory team.</li>
<li>Represent the Regulatory Affairs function in internal and external meetings, providing strategic insights to support business and development goals.</li>
</ul>
</li></ul>Required qualifications:
<ul>
<li>Education: Advanced degree in life sciences, pharmacy, or a related field.</li>
<li>Experience: 7&ndash;10+ years of experience in Regulatory Affairs within the pharmaceutical or biotechnology industry.</li>
<li>Proven track record of leading and successfully managing ANDA, IND, NDA, submissions and approvals with the FDA.</li>
<li>Experience in regulatory strategy planning for generic drugs and combination products.</li>
<li>
Strong knowledge of FDA regulations and guidelines, including regulatory requirements for preclinical, clinical, and CMC submissions.
</li>
<li>Exceptional project management skills with the ability to manage multiple priorities and deadlines.
</li>
<li>Strong analytical and problem-solving skills with a proactive and solutions-oriented mindset.
</li>
<li>Excellent communication and interpersonal skills for effective collaboration with internal teams, external partners, and regulatory agencies.
</li>
</ul>Preferred qualifications:
<ul>
<li>The ideal candidate would have at least 7 years of experience working in Regulatory Affairs, at successful generic pharmaceutical companies in the US, on ANDA submissions.</li>
</ul>
Padagis Core Competencies:

Since its beginning, Padagis has been undergoing the process of identifying what we believe will lead to the success of our organization in a competitive landscape. To that end, we have developed a set of five &ldquo;core&rdquo; competencies. We strive to bring employees on board the journey with us who exemplify these key competencies:
<ul>
<li>Service delivery &ndash; Understand who your internal and external customers are, identify their needs, and deliver value above their expectations&hellip;</li>
<li>Active collaboration &ndash; Seek opportunities to work together across teams, function, business units, and geographies to seek success&hellip;</li>
<li>Demonstrate agility &ndash; Proactively identify changes in our environment and act quickly, leading or embracing change&hellip;</li>
<li>Think differently &ndash; Create, develop, and implement new ideas, products, services, or processes that involve introducing something new or significantly improving something that already exists&hellip;</li>
<li>Excellent execution &ndash; Achieve outstanding results in all aspects of our organization, including our culture, leadership, strategy, and processes&hellip;</li>
</ul>
About Us:

At Padagis our focus is on health care products that improve people&rsquo;s lives. We are a market-leading generic prescription pharmaceutical company that specializes in &ldquo;extended topical&rdquo; medications, like creams, foams, mousses, gels, liquids and inhalable products. It&rsquo;s a great time to join our team because we have a high growth trajectory with now more than 1,300 employees across six locations in the United States and Israel. We&rsquo;ve already established a successful track record of launching first-to-file and first-to-market generic pharmaceutical products that have helped to make prescription products more affordable for patients and reduce costs for the healthcare system. Our team members work in a dynamic environment where opportunity is built on a foundation of honesty and transparency. Please consider joining our team where great things are happening and you can make a difference.

What&rsquo;s Next:

At Padagis a real recruiter AND the hiring manager will review your application, not just a bot. This means we pay special attention to each application submitted for the position. While it could take a couple of days for us to get back with you, please know that we appreciate you applying for the open position and ask that you monitor your email for updates.</div>

Associate Director/Director for Regulatory Affairs

Stellar Hunters

<div><h4 class="jobSectionHeader">Job Summary</h4>
We are seeking a detail-oriented and knowledgeable Regulatory Affairs Specialist to ensure that products, processes, and operations comply with applicable regulatory requirements. The successful candidate will support product registrations, maintain regulatory documentation, and liaise with regulatory authorities to ensure timely approvals and ongoing compliance.
This role requires strong understanding of regulatory frameworks, documentation accuracy، and the ability to work cross-functionally in a fast-paced, compliance-driven environment.<h4 class="jobSectionHeader">
Key Responsibilities</h4><h5 class="jobSectionHeader">
Regulatory Submissions &amp; Approvals</h5><ul><li>
Prepare, review, and submit regulatory dossiers and documentation to relevant authorities (e.g., SFDA or other applicable bodies).</li><li>
Track and manage product registration timelines, renewals, and approvals.</li></ul><h5 class="jobSectionHeader">
Compliance &amp; Documentation</h5><ul><li>
Ensure all products and processes comply with local and international regulatory requirements.</li><li>
Maintain up-to-date regulatory documentation, technical files, and records.</li></ul><h5 class="jobSectionHeader">
Regulatory Intelligence</h5><ul><li>
Monitor changes in regulations and guidelines and assess their impact on the business.</li><li>
Communicate regulatory updates to internal stakeholders and recommend necessary actions.</li></ul><h5 class="jobSectionHeader">
Cross-functional Collaboration</h5><ul><li>
Work closely with R&amp;D, Quality, Manufacturing, and Marketing teams to ensure compliance throughout the product lifecycle.</li><li>
Support new product development by providing regulatory guidance and requirements.</li></ul><h5 class="jobSectionHeader">
Audit &amp; Inspection Support</h5><ul><li>
Support internal and external audits, inspections, and regulatory inquiries.</li><li>
Ensure readiness and proper documentation for compliance reviews.</li></ul><h5 class="jobSectionHeader">
Labeling &amp; Claims Review</h5><ul><li>
Review product labeling, packaging, and marketing materials to ensure regulatory compliance.</li><li>
Ensure all product claims are supported and aligned with regulatory standards.</li></ul><h5 class="jobSectionHeader">
Continuous Improvement</h5><ul><li>
Identify opportunities to improve regulatory processes, documentation systems, and submission workflows.</li></ul><h4 class="jobSectionHeader">
Required Qualifications - Skills &amp; Experience</h4><ul><li>
Bachelor&rsquo;s degree in Pharmacy, Life Sciences, Chemistry, or a related field.</li><li>
2&ndash;5 years of experience in regulatory affairs, preferably within pharmaceutical, medical device, or FMCG industries.</li><li>
Strong knowledge of regulatory frameworks and submission processes.</li><li>
Experience with product registration and regulatory documentation.</li><li>
Excellent attention to detail and organizational skills.</li><li>
Strong communication and stakeholder management skills.</li></ul><h4 class="jobSectionHeader">
Preferred Qualifications</h4><ul><li>
Experience with Saudi regulatory bodies such as SFDA.</li><li>
Familiarity with GCC or international regulatory requirements.</li><li>
Experience with electronic submission systems and regulatory databases.</li><li>
Certification or training in regulatory affairs is a plus.</li></ul><h4 class="jobSectionHeader">
Work Environment &amp; Compensation</h4><ul><li>
Full-time position with an onsite model.</li><li>
Competitive salary commensurate with experience and a comprehensive benefits package, including health insurance, retirement plan options, and paid time off.</li><li>
Opportunities for professional development, training, and certification support; clear paths for career growth within IT and cross-functional teams.</li><li>
Inclusive culture that values diversity, equity, work-life balance, and employee well-being.</li></ul></div>

Regulatory Affairs Specialist

Checkout.com

<div>Company Description
We&rsquo;re Checkout.com &ndash; you might not know our name, but companies like eBay, ASOS, Klarna, Uber Eats, and Sony do. That moment when you check out online? We make it happen.
Checkout.com is where the world checks out. Our global network powers billions of transactions every year, making money move without making a fuss. We spent years perfecting a service most people will never notice. Because when digital payments just work, businesses grow, customers stay, and no one stops to think about why.
With 19 offices spanning six continents, we feel at home everywhere &ndash; but London is our HQ. Wherever our people work their magic, they&rsquo;re fast-moving, performance-obsessed, and driven by being better every day. Ideal. Because a role here isn&rsquo;t just another job; it&rsquo;s a career-defining opportunity to build the future of fintech.
Job Description
You will be leading external affairs in one of Checkout.com&rsquo;s most important geographies.
The External Affairs team sits within the Legal, Risk and Compliance department, and manages Checkout.com&rsquo;s engagement with regulators, governments and other third parties. External Affairs at Checkout.com covers regulatory affairs, public policy, government relations and licensing.
This is Checkout.com&rsquo;s first External Affairs role in the MENA region, meaning you can really make your mark. You will be working with all areas of the business and be the primary architect of the company&rsquo;s reputation in a strategic growth market. You will have a seat at the table with local executives and the freedom to shape how Checkout.com is perceived by the government and regulator.
If you thrive in high-stakes environments, enjoy solving difficult problems, excel at building relationships and influencing people, and want to be the face of our public policy strategy in the region, this is the role for you.
What you&rsquo;ll do<ul><li>
Build relationships: Cultivate and maintain strong relationships with regulators, government bodies and relevant third parties. You will ensure Checkout.com is viewed as a strategic partner.</li><li>
Regulatory affairs: Work with the Legal and Compliance team to handle regulatory enquiries, with a particular focus on narrative and positioning.</li><li>
Advocacy: You will design and execute advocacy campaigns to secure Checkout.com&rsquo;s regulatory priorities, delivering positive commercial outcomes.
</li><li>Public policy: Analyse legislation to understand opportunities and risks. Influence fintech policy in the MENA region before it becomes law.</li><li>
Narrative: Craft a UAE specific external narrative and then tell the Checkout.com story.</li><li>
Industry advocacy: Represent Checkout.com in industry associations, forums and conferences.</li></ul>
What we are looking for<ul><li>
6+ years of experience working in external affairs (public affairs agency, in-house role, trade body), or in government or a financial services regulator.</li><li>
A strong understanding of the UAE political and regulatory machinery, with an ability to navigate the local landscape effectively</li><li>
A proven ability to build deep relationships and influence decisions</li><li>
The ability to analyse complex technical policy and create actionable strategies (You do not need to be a financial services expert but you must prove that you have the ability to understand a new and complex subject quickly)</li><li>
A track record of keeping calm under pressure</li><li>
A practical, solutions-oriented focus and enthusiasm for taking on new challenges</li><li>
Impeccable written communication skills to be able to deliver a message succinctly</li><li>
Being comfortable using data is a strong advantage</li><li>
Fluency in Business Arabic (spoken and written) is a strong advantage</li><li>
Previous FinTech, payments, software, e-commerce and/or bank experience is desirable but not essential</li><li>
Experience working in a start up or other fast-paced and dynamic environment is desirable but not essential</li></ul>
Bring all of you to work
We create the conditions for high performers to thrive &ndash; through real ownership, fewer blockers, and work that makes a difference from day one.
Here, you&rsquo;ll move fast, take on meaningful challenges, and be recognized for the impact you deliver. It&rsquo;s a place where ambition gets met with opportunity &ndash; and where your growth is in your hands.
We work as one team, and we back each other to succeed. So whatever your background or identity, if you&rsquo;re ready to grow and make a difference, you&rsquo;ll be right at home here.
It&rsquo;s important we set you up for success and make our process as accessible as possible. So let us know in your application, or tell your recruiter directly, if you need anything to make your experience or working environment more comfortable. 
Life at Checkout.com
We understand that work is just one part of your life. Our hybrid working model offers flexibility, with three days per week in the office to support collaboration and connection.
Curious about what it&rsquo;s like to be part of our team? Visit our Careers Page to learn more about our culture, open roles, and what drives us.
For a closer look at daily life at Checkout.com, follow us on LinkedIn and Instagram</div>

Manager, External Affairs - UAE

Ghrasa Laboratory

We Are Hiring: DRAP Regulatory Affairs OfficerWe are looking for an experienced and detail-oriented DRAP Regulatory Affairs Officer to join our growing team and ensure full compliance with regulatory requirements for medical and laboratory equipment in Pakistan.Key Responsibilities:<ul><li>Manage product registrations with DRAP (Class A, B, C &amp; D devices)</li><li>Ensure compliance with DRAP rules, guidelines, and documentation</li><li>Prepare and submit regulatory dossiers and technical files</li><li>Liaise with DRAP officials and regulatory bodies</li><li>Monitor regulatory updates and implement changes internally</li><li>Support marketing team with compliant product claims and advertisements</li></ul>Requirements:<ul><li>Bachelor&rsquo;s/Master&rsquo;s in Pharmacy or relevant field</li><li>3&ndash;5 years of experience in DRAP regulatory affairs</li><li>Strong knowledge of DRAP regulations and medical device classification</li><li>Experience with product registration and licensing processes</li><li>Excellent documentation and communication skills</li></ul>What We Offer:<ul><li>Competitive salary package with other company benefits</li><li>Career growth in a rapidly expanding company</li><li>Professional and compliance-driven work environment</li></ul>Apply Now: Send your CV to: HR@ghrasa.com Whatsapp: 0317-3172913Only shortlisted candidates will be contactedWork Location: In person

DRAP Regulatory Affairs Officer

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