senior regulatory affairs specialist

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

EVA pharma

<div>
 
 Join EVA Pharma, a leading pharmaceutical company dedicated to empowering the fight for Health and well-being as a fundamental human right. Recognized and certified as a best place to work, we are committed to fostering a supportive and innovative environment for our team members.
 
 &nbsp;
 
 
 
 Job Summary:
 
 
 
 We are seeking a passionate and talented
 
 Regulatory Affairs Specialist
 
 to join our dynamic team.
 
 
 The ideal candidate will contribute to our mission of enhancing human health and well-being, ensuring that we meet the highest standards of excellence in our industry.
 
 
 
 
 
 Key Responsibilities:
 
 
 
 
 <ul>
 <li>
 Regulatory Compliance - Ensure all products meet international regulations, serving as the primary regulatory contact for our international hubs
 </li>
 <li>
 Product Registration - Prepare, submit, and manage dossiers for new drugs, renewals, and variations, guiding approvals from start to finish
 </li>
 <li>
 Compliance Monitoring - Stay ahead of evolving regulations, advising internal teams on critical updates to maintain full compliance
 </li>
 <li>
 Labeling &amp; Packaging Review - Ensure all pharma labeling, packaging, and promotional materials adhere to regulatory standards
 </li>
 <li>
 Cross-Functional Collaboration - Partner with R&amp;D, QA, Manufacturing, and Marketing to embed regulatory requirements at every stage
 
 </li>
 </ul>
 
 
 Qualifications:
 
 
 
 
 <ul>
 <li>
 Bachelor's degree in Pharmaceutical Sciences
 </li>
 <li>
 +2 years of experience in Regulatory Affairs in international Markets.
 </li>
 <li>
 Fluent in English (written &amp; verbal) - essential for global collaboration
 </li>
 <li>
 Detail-oriented, proactive, and eager to grow in a dynamic regulatory landscape
 </li>
 </ul>
 
 
</div>

Nitaq Al Geldia

Job Requirements:<ul><li>Bachelor&rsquo;s degree in Pharmacy, Life Sciences, or a related field</li><li>Minimum of 2&ndash;3 years of experience in Regulatory Affairs</li><li>Strong experience in eCTD (electronic Common Technical Document) submissions</li><li>Good knowledge of local and international regulatory guidelines (e.g., SFDA, FDA, EMA)</li><li>Experience in preparing, reviewing, and submitting regulatory dossiers</li><li>Familiarity with product registration and lifecycle management</li><li>Excellent documentation and organizational skills</li><li>Strong attention to detail and ability to meet deadline</li></ul>Work Location: Remote

Regulatory Affairs Specialist (Remote – Full Time)

Clark Associates

<div><h2 class="jobSectionHeader">Job Summary</h2>
The Senior Manager of Regulatory Affairs plays a critical leadership role in guiding and executing regulatory strategy across Clark Associates&rsquo; product portfolio. Reporting to the Director of Regulatory Affairs, this role is responsible for managing a regulatory team, navigating complex federal and state regulatory frameworks, and supporting process improvement as the team grows. 
 
This role requires deep experience working with U.S. regulatory bodies such as the FDA, FTC, EPA, and CPSC, as well as the judgment and communication skills needed to manage regulatory nuance, ambiguity, and competing business priorities. The ideal candidate brings both technical regulatory expertise and proven people leadership experience, with a strong preference for experience in sustainability and environmental regulations impacting plastics, paper, and disposable products.<h2 class="jobSectionHeader">
Responsibilities</h2><ul><li>
Lead, manage, and develop a team of regulatory professionals, providing coaching, prioritization, performance management, and professional growth support.</li><li>
Oversee regulatory strategy and execution across applicable federal, state, and local requirements, including but not limited to FDA, FTC, EPA, and CPSC obligations.</li><li>
Monitor, interpret, and assess new and emerging regulations, translating regulatory requirements into clear, actionable guidance for cross-functional business teams.</li><li>
Partner closely with Trade, Quality, Sourcing, Merchants and Legal to enable compliant product development, labeling, claims, and commercialization.</li><li>
Lead regulatory impact assessments for changes in law or guidance, including mitigation strategies and recommended business actions.</li><li>
Represent the company in interactions with regulatory agencies, trade associations, and external stakeholders as appropriate.</li><li>
Develop and maintain internal regulatory processes, guidance documents, and training materials to drive consistency and institutional knowledge.</li><li>
Support enterprise compliance initiatives, including audits, investigations, and response to regulatory inquiries.</li><li>
Prepare summaries, briefings, and recommendations to support leadership decision-making.</li><li>
Contribute to the continued development and maturity of the Regulatory Affairs function as the business scales.</li></ul><h2 class="jobSectionHeader">
Physical Requirements</h2><ul><li>
Work is performed while sitting/standing and interfacing with a personal computer.</li><li>
Requires the ability to communicate effectively using speech, vision, and hearing.</li><li>
Requires the regular use of hands for simple grasping and fine manipulations.</li><li>
Requires occasional bending, squatting, crawling, climbing, and reaching.</li><li>
Requires the ability to occasionally lift, carry, push, or pull medium weights, up to 50lbs.</li></ul><h2 class="jobSectionHeader">
Remote Work Qualifications</h2><ul><li>
Access to a reliable and secure high-speed internet connection. Cable or fiber internet connections (at least 75mbps download/10mbps upload) are preferred, as satellite connections often cannot support the technologies used to perform day-to-day tasks.</li><li>
Access to a home router and modem.</li><li>
A dedicated home office space that is noise- and distraction-free. The space should have strong wireless connection or a wired Ethernet connection (wired connection is preferred, if possible).</li><li>
A valid, physical address (apartment, suite, etc.). PO Boxes are not supported, as a physical address is required for you to receive your computer equipment.</li><li>
The desire and ability to work and communicate with other team members via chat, webcam, etc.</li><li>
Legal residents of one of the following states: (AK, AL, AR, AZ, CT, DE, FL, GA, IA, ID, IN, KS, KY, LA, MD, ME, MI, MN, MO, MS, NC, ND, NH, NM, NV, OH, OK, PA, SC, SD, TN, TX, UT, VA, VT, WI, WV, or WY). H-1B Visa Sponsorship Not Available, W2 only.</li></ul><h2 class="jobSectionHeader">
Experience</h2><ul><li>
5+ years of experience managing people in a regulatory, compliance, or related function.</li><li>
Demonstrated experience navigating U.S. federal and state regulations, including interaction with agencies such as FDA, FTC, EPA, and CPSC.</li><li>
Experience evaluating and interpreting regulatory requirements across complex or evolving compliance landscapes.</li><li>
Preferred experience with sustainability, environmental, or materials-based regulations impacting plastics, paper, and disposable products.</li><li>
Proven ability to provide practical, business-focused regulatory guidance.</li></ul><h2 class="jobSectionHeader">
Education</h2>
This role does not require a degree. We value relevant skills and experience and alignment with our core values above all else.<h2 class="jobSectionHeader">
Desired Traits &amp; Skills</h2><ul><li>
Strong leadership presence with the ability to influence, mentor, and build high-performing teams.</li><li>
Comfortable navigating nuance, ambiguity, and competing regulatory interpretations.</li><li>
Excellent communication skills, with the ability to translate complex regulatory concepts into clear guidance for non-technical audiences.</li><li>
Highly organized, with the ability to manage multiple priorities in a fast-paced, evolving environment.</li><li>
Collaborative and solutions-oriented approach to cross-functional problem solving.</li><li>
High level of professionalism, discretion, and integrity when handling sensitive regulatory matters.</li></ul><h2 class="jobSectionHeader">
Company Overview</h2>
A rapidly growing, multi-divisional company headquartered in Lancaster, Pennsylvania with services supporting all of Clark&rsquo;s distribution methods in the food service industry.<h2 class="jobSectionHeader">
Benefits</h2><ul><li>
Medical</li><li>
Vision</li><li>
Dental</li><li>
PTO</li><li>
Paid Maternity Leave</li><li>
Paid Parental Leave</li><li>
Life Insurance</li><li>
Disability</li><li>
Dependent Care FSA</li><li>
401(k) matching</li><li>
Employee Assistance Program</li><li>
Wellness Incentives</li><li>
Company Discounts</li><li>
AT&amp;T &amp; Verizon Discount</li><li>
Bonus Opportunities</li><li>
Accident Insurance</li><li>
Critical Illness Insurance</li><li>
Adoption Assistance</li></ul><h3 class="jobSectionHeader">
Available at HQ Locations Only</h3><ul><li>
On-Site Fitness Centers</li><li>
Dog-friendly Offices</li></ul></div>

Senior Manager, Regulatory Affairs

Amgen

<div>
 HOW MIGHT YOU DEFY IMAGINATION?
 
 
 <ul>
 <li>
 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.
 
 
 </li>
 </ul>
 Job purpose:
 
 
 <ul>
 <li>
 As a member of this fast-pace, complex and dynamic region, MEA Regulatory Affairs Senior Associate will be accountable for labeling and packaging activities management for Middle East North African region for Amgen portfolio for pipeline, inline and biosimilars; as well participating in labeling projects internally and externally for e-labeling implementation; and execution of Regulatory Affairs processes in the local office.
 
 
 </li>
 </ul>
 Job Responsibilities:
 
 
 <ul>
 <li>
 Deliver both strategic and administrative system support for ongoing maintenance with Lifecyle management and updates to our existing platforms and systems, to ensure data standards are 100% accurate, as to enable effective reporting and data analytics
 </li>
 <li>
 Manage Performance Excellence through collection, analyzing &amp; disseminating relevant information to team(s) as appropriate
 </li>
 <li>
 Participate in local regulatory process improvements initiatives
 </li>
 <li>
 Build newsletter, annual Report, data analysis with follow up on Key Performance Indicators and Metrics
 </li>
 <li>
 Ensure delivery of right first time label source text for artwork creation
 </li>
 <li>
 Support efficiently the filing plan of different marketing application submissions and products life cycle management filings by providing regional product information (leaflet and SmPC) source texts and artworks in a timely manner
 </li>
 <li>
 Ensure implementation of master artworks as per Amgen procedures, SKU strategy and timelines with high quality to serve our patients in MENA region
 </li>
 <li>
 Access the translation agency systems to request the label translation and track the job readiness and timelines.
 </li>
 <li>
 Perform regional prescribing information translation review: 100% review of both content and format
 </li>
 <li>
 Perform the role of source text owner/approver and artwork reviewer/approver in the system
 </li>
 <li>
 Trigger the existing label revision when alerted by global RA team.
 </li>
 <li>
 Support in product launch and ensure supply continuity by creating and revising the commercial pack artworks (leaflet, label, blister, outer pack)
 </li>
 <li>
 Collate, distribute and exchange regulatory information with other regulatory colleagues and cross functional teams on an ongoing basis and provide advice on local regulatory considerations in a timely manner.
 
 
 </li>
 </ul>
 Qualifications:
 
 
 <ul>
 <li>
 Experience +2 years in Regulatory Affairs
 </li>
 <li>
 Current/ previous experience in working as part of an MNC employer
 </li>
 <li>
 Pharmacist, biologist, chemist-medical background
 </li>
 <li>
 Fluent in English and Arabic for translation review purpose ( French is a huge plus)
 </li>
 <li>
 A minimum knowledge of Middle East Africa regulatory requirements
 </li>
 <li>
 Strong communication skills (verbal &amp; written) with ability to understand and communicate the scientific information and anticipate/prevent potential issues
 </li>
 <li>
 Conflict Management skillset &amp; ability to deal with multiple stakeholders simultaneously.
 
 
 </li>
 </ul>
 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.
 
 
 We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
</div>

MEA Regulatory Affairs Senior Associate

<div><h2 class="jobSectionHeader">HOW MIGHT YOU DEFY IMAGINATION?</h2><ul><li> 
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.</li></ul><h2 class="jobSectionHeader">
Job purpose:</h2><ul><li> 
As a member of this fast-pace, complex and dynamic region, MEA Regulatory Affairs Senior Associate will be accountable for labeling and packaging activities management for Middle East North African region for Amgen portfolio for pipeline, inline and biosimilars; as well participating in labeling projects internally and externally for e-labeling implementation; and execution of Regulatory Affairs processes in the local office.</li></ul><h2 class="jobSectionHeader">
Job Responsibilities:</h2><ul><li>
Deliver both strategic and administrative system support for ongoing maintenance with Lifecyle management and updates to our existing platforms and systems, to ensure data standards are 100% accurate, as to enable effective reporting and data analytics</li><li>
Manage Performance Excellence through collection, analyzing &amp; disseminating relevant information to team(s) as appropriate</li><li>
Participate in local regulatory process improvements initiatives</li><li>
Build newsletter, annual Report, data analysis with follow up on Key Performance Indicators and Metrics</li><li>
Ensure delivery of right first time label source text for artwork creation</li><li>
Support efficiently the filing plan of different marketing application submissions and products life cycle management filings by providing regional product information (leaflet and SmPC) source texts and artworks in a timely manner</li><li>
Ensure implementation of master artworks as per Amgen procedures, SKU strategy and timelines with high quality to serve our patients in MENA region</li><li>
Access the translation agency systems to request the label translation and track the job readiness and timelines.</li><li>
Perform regional prescribing information translation review: 100% review of both content and format</li><li>
Perform the role of source text owner/approver and artwork reviewer/approver in the system</li><li>
Trigger the existing label revision when alerted by global RA team.</li><li>
Support in product launch and ensure supply continuity by creating and revising the commercial pack artworks (leaflet, label, blister, outer pack)</li><li>
Collate, distribute and exchange regulatory information with other regulatory colleagues and cross functional teams on an ongoing basis and provide advice on local regulatory considerations in a timely manner.</li></ul><h2 class="jobSectionHeader">
Qualifications:</h2><ul><li>
Experience +2 years in Regulatory Affairs</li><li>
Current/ previous experience in working as part of an MNC employer</li><li>
Pharmacist, biologist, chemist-medical background</li><li>
Fluent in English and Arabic for translation review purpose ( French is a huge plus)</li><li>
A minimum knowledge of Middle East Africa regulatory requirements</li><li>
Strong communication skills (verbal &amp; written) with ability to understand and communicate the scientific information and anticipate/prevent potential issues</li><li>
Conflict Management skillset &amp; ability to deal with multiple stakeholders simultaneously.</li></ul>
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><h2 class="jobSectionHeader">
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. 
 
We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.</h2></div>

SkyBlue Media

<div>This position will be based in Dubai UAE. Please apply if you are in Dubai or OPEN FOR RELOCATION.
The top budget for this role is 15K AED to 20K AED per month. Please apply accordingly
Role Overview
Antweave is seeking a high-caliber Regulatory Affairs &amp; Licensing Lead to spearhead our institutional entry into the UAE&rsquo;s digital asset ecosystem.
You will be the primary architect of our licensing strategy, responsible for securing and maintaining our VARA (Virtual Assets Regulatory Authority) Full Market Product licenses and navigating the RAK Digital Assets Oasis (RAK DAO) legal frameworks.
Your mission is to ensure that our platform for fractional ownership of Real-World Assets (RWA) is not just compliant, but sets the gold standard for regulated tokenization in the region.
<h4 class="jobSectionHeader">Key Responsibilities
</h4>1. Licensing &amp; Statutory Approvals<ul><li>
VARA Management: Lead the end-to-end application process for VARA licenses (specifically Broker-Dealer).
</li><li>RAK DAO Integration: Manage the setup and &quot;legal wrapper&quot; structures within RAK DAO, ensuring our DAO governance aligns with Ras Ras Ras Al Khaimah&rsquo;scifice zone regulations.
</li><li>Regulatory Liaison: Act as the primary point of contact for regulators, managing all inspections, audits, and &quot;No Objection Certificate&quot; (NOC) requests.
</li></ul>2. Compliance Framework Development
<ul><li>Rulebook Implementation: Translate VARA&rsquo;s Compulsory Rulebooks (Compliance &amp; Risk, AML/CFT, Cybersecurity, etc.) into actionable internal SOPs.
</li><li>RWA Legal Structuring: Collaborate with legal counsel to ensure the &quot;off-chain&quot; asset (real estate, art, etc.) is perfectly mirrored by the &quot;on-chain&quot; token under UAE Law.
</li><li>Investor Onboarding: Oversee the development of KYC/KYB and AML workflows that satisfy both UAE federal law and specific Virtual Asset standards.
</li></ul>3. Strategic Advisory
<ul><li>Product Roadmap Alignment: Advise the tech and product teams on how new features (e.g., secondary market trading or staking) impact our licensing perimeter.
</li><li>Governance: Help establish the Board-level Risk and Compliance Committees required for regulated financial entities in Dubai.
</li></ul>Candidate Profile Experience &amp; Qualifications:
<ul><li>6+ years of experience in legal, compliance, or regulatory affairs within Fintech, Blockchain, or Traditional Finance (Private Equity/REITs).
</li><li>Proven Track Record: Direct experience in successfully obtaining licenses from VARA, ADGM (FSRA), or DIFC (DFSA).
</li><li>RWA Knowledge: Deep understanding of the legal hurdles involved in fractionalizing physical assets (SPV structures, land registry integrations, etc.).
</li><li>Education: Bachelor&rsquo;s or Master&rsquo;s degree in Law, Finance, or a related field. Professional certifications (CAMS, ICA) are highly preferred. Soft Skills:
</li><li>The &quot;VARA Whisperer&quot;: Exceptional communication skills with the ability to present complex technical concepts to regulators clearly.
</li><li>Entrepreneurial Grit: Comfortable working in a fast-paced startup environment where the regulatory &quot;goalposts&quot; are often moving.
</li></ul>Why Join Antweave?<ul><li>
Be at the forefront of the $16 Trillion RWA tokenization market.
</li><li>Shape the regulatory landscape of the UAE&rsquo;s most ambitious Web3 project.
</li><li>Competitive salary + equity/token options</li></ul></div>

Head of Regulatory Affairs & Licensing (RWA Tokenization)

Search 10000+ Senior regulatory affairs specialist jobs near you this April. New roles added regularly across leading industries. Apply today.

10000 senior regulatory affairs specialist jobs Near Me

Regulatory Affairs Specialist

Regulatory Affairs Specialist

Regulatory Affairs Specialist (Remote – Full Time)

Senior Manager, Regulatory Affairs

MEA Regulatory Affairs Senior Associate

MEA Regulatory Affairs Senior Associate

Head of Regulatory Affairs & Licensing (RWA Tokenization)