manager of regulatory affairs

Grifols Egypt for Plasma Derivatives (GEPD)

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

Regulatory Affairs Sr. Manager

Sanofi

<div>EM&amp;S Turkey Regulatory Affairs Officer<ul><li>
Location: Istanbul</li></ul>
About the job
Reporting to the EM&amp;S Middle East Quality Manager, the Regulatory Affairs Officer supports regulatory compliance and lifecycle activities related to External Manufacturing &amp; Supply operations. The role ensures alignment between regulatory dossiers and industrial practices at CMO, in compliance with local regulations and Sanofi standards, and acts as a key interface between Affiliate Regulatory Affairs and CMO.
This position contributes to the implementation of Sanofi&rsquo;s Quality and Regulatory policies within External Manufacturing &amp; Supply activities, ensuring regulatory compliance of manufactured products, supporting product lifecycle management, and enabling timely execution of regulatory-impacting changes and transfers.
Main responsibilities:<ul><li>
Regulatory Compliance &amp; Lifecycle Management<ul><li>
Ensure regulatory compliance between CMC dossiers / Marketing Authorizations and manufacturing practices at CMOs</li><li>
Coordinate the regulatory compliance exercise with the assigned Hub</li><li>
Maintain regulatory compliance of manufactured products throughout their lifecycle (variations, renewals, annual updates)</li><li>
Support the preparation, maintenance, and update of CMC dossiers for assigned products</li><li>
Assess the regulatory impact of proposed changes (change controls) originating from CMO or internal sites</li><li>
Support Product Registration Renewals and periodic regulatory submissions (Annual Reports, PQRs&hellip;)</li><li>
Contribute to the implementation of Sanofi Quality policy across External Manufacturing activities</li></ul></li><li>
Regulatory Interface &amp; Submissions Support<ul><li>
Act as the regulatory interface between Affiliate Regulatory Affairs, site Regulatory teams, CMOs, and the Hub</li><li>
Consolidate industrial and technical data required for local and regional registrations and variations</li><li>
Support responses to Health Authority requests (RFI, deficiency letters)</li><li>
Monitor submission and approval status and ensure appropriate communication of regulatory approvals and implementation timelines</li><li>
Perform regulatory review and approve documentation provided by the Hub prior to submission while ensuring documentation management within Sanofi systems (Veeva Vault)</li><li>
Manage regulatory activities in Veeva Vault (Regulatory Objective, SCP&hellip;)</li><li>
Participate in Quality System activities, including Change Control, CAPA, PQR, training, and documentation management</li><li>
Support regulatory aspects of technology transfers, product transfers, and site projects in collaboration with Quality, Supply Chain, and Project teams</li><li>
Prepare the Variation Record Card (VRC) for product divestments</li></ul></li><li>
Site Compliance &amp; Regulatory Maintenance<ul><li>
Compile and maintain product specification files and support updates of the Site Master File (SMF)</li><li>
Support the maintenance of manufacturing licenses, GMP certificates, site registrations, and renewals</li><li>
Participate in internal audits, external audits, and regulatory inspections, supporting preparation and follow-up activities</li><li>
Contribute to continuous improvement initiatives related to Regulatory Affairs processes and procedures</li></ul></li><li>
HSE &amp; Compliance Awareness<ul><li>
Ensure compliance with applicable HSE rules and procedures</li><li>
Report accidents and incidents occurring in the workplace in line with internal requirements</li><li>
Support site and Quality initiatives promoting compliance and quality culture (Quality Day)</li></ul></li><li>
Compliance &amp; Ethics<ul><li>
Comply with the Company's Code of Ethics, upholding high professional standards of conduct</li><li>
Demonstrate a commitment to protecting and enhancing the Company's reputation</li><li>
Maintain comprehensive knowledge of regulatory guidance, technical developments, ethics, and governance requirements relevant to the role</li><li>
Apply ethical principles and governance standards to all work activities</li></ul></li></ul>
About you
<ul><li>Education: Bachelor&rsquo;s degree or higher in Pharmacy, Chemistry, Microbiology, Quality, or a related scientific field</li><li>
Experience: At least 5 years&rsquo; experience in the pharmaceutical industry, preferably with 2 years+ in a similar role, working in a regulatory team.<ul><li>
Proven ability to manage multiple priorities effectively</li><li>
Experience in management of change control with regulatory impact</li></ul></li><li>
Skills:
<ul><li>Good knowledge of pharmaceutical regulatory requirements (EU and local regulations)</li><li>
Understanding of CMC dossiers, variations, and product lifecycle management</li><li>
Familiarity with External Manufacturing / CMO environments is a plus</li><li>
Working knowledge of Quality Systems (Change Control, CAPA)</li><li>
Ability to compile, review, and manage technical and regulatory documentation</li><li>
Comfortable using digital tools (Excel, PowerPoint, and regulatory document management systems)</li></ul></li><li>
Languages: Fluency in English is required, knowledge of other languages is an asset</li></ul>
Why choose us?<ul><li>
Shape the future of medicine and vaccine delivery with cutting-edge technology, ensuring seamless launches and a resilient global supply.</li><li>
Be part of an organization that invests in people, technology, and sustainability, leading the industry in low-carbon manufacturing and digital transformation.</li></ul>
#LI-EUR
null</div>

EM&S Turkey Regulatory Affairs Officer

Stryker

<div><h3 class="jobSectionHeader">Why join Stryker?</h3>
Looking for a place that values your unique talents? Discover Stryker's award-winning culture. 
We are proud to offer you our total rewards package which includes bonuses, healthcare, insurance benefits, retirement programs, wellness programs, as well as service and performance awards &ndash; not to mention various social and recreational activities, all of which are location specific.<h3 class="jobSectionHeader">
Job description</h3>
We are excited to be named one of the World&rsquo;s Best Workplaces by Fortune Magazine! We are proud to offer you 12 paid holidays annually. For an overview of our benefits and time off, please follow this link to learn more:US Stryker employee benefits.<div>
Stryker is hiring a Senior Regulatory Affairs Specialist to support Sports Medicine in Denver, CO! In this role, you will develop and implement regulatory strategies, ensure compliance across the product lifecycle, manage regulatory submissions, advise stakeholders on regulatory requirements, and engage with regulatory authorities to resolve issues and support market access.
What you will do:<ul><li>
Develop and update regulatory strategies at the local, regional, and global levels by monitoring regulatory intelligence and emerging requirements.</li><li>
Determine product classification, submission requirements, and approval pathways, preparing and submitting regulatory filings in alignment with applicable guidelines.</li><li>
Assess the regulatory landscape and provide guidance across the product lifecycle to support compliant development, manufacturing, and commercialization.</li><li>
Identify potential regulatory obstacles, anticipate upcoming issues, and recommend practical solutions to maintain compliance and support market access.</li><li>
Review quality, preclinical, and clinical documentation to ensure readiness for regulatory submissions and consistency with regulatory expectations and product claims.</li><li>
Evaluate proposed device modifications to determine necessary regulatory actions</li><li>
Support interactions with regulatory authorities by contributing to communication, tracking submission progress, and preparing required documentation.</li><li>
Provide regulatory input on product labeling and claims, ensuring that clinical and nonclinical data, in conjunction with regulatory strategy, are consistent with the regulatory requirements and support the proposed product claims.</li></ul>
What you need:
Required:<ul><li>
Bachelors degree</li><li>
Minimum of 3+ years of regulatory affairs experience within a regulated industry (e.g., medical devices, IVDs, pharmaceuticals, biotechnology, or healthcare products).</li><li>
Demonstrated experience in project management, regulatory writing, and coordinating and executing regulatory submissions and deliverables.</li></ul>
Preferred:<ul><li>
Bachelors degree in Regulatory Science, or technical discipline (Engineering or Life Sciences)</li><li>
Experience engaging with regulatory authorities to support submissions, respond to inquiries, and facilitate successful interactions throughout the product lifecycle.</li><li>
RAC(s) certification</li></ul>
83,300.00 to 180,400.00 salary plus bonus eligible + benefits. Actual minimum and maximum may vary based on location. Individual pay is based on skills, experience, and other relevant factors. 
Posted Date: 03/19/2026 
This role will be posted for a minimum of 3 days.</div>
Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&amp;D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.</div>

Senior Regulatory Affairs Specialist

Olema Oncology

<div><div>Olema Oncology is dedicated to developing better medicines for breast cancer and beyond. Our lead program, palazestrant (OP-1250), is a complete estrogen receptor antagonist (CERAN) currently in development for metastatic breast cancer with blockbuster potential as a monotherapy and in combination in ER+/HER2- metastatic breast cancer. Our follow-on product candidate, OP-3136, is a potent KAT6 inhibitor with best-in-class potential.
Our scientific breakthroughs are accelerated through the ways in which we fearlessly support, motivate, and challenge one another. At Olema, we know that when we put people first, our work becomes second to none. If you're ready to join us at the edge of something unstoppable, let's make a profound impact together for our patients, for your career, for what's beyond.

You can view our latest corporate deck and other presentations here.</div>
About the Role &gt;&gt;&gt; Submission Content Manager, Regulatory Operations

The Submission Content Manager plays a critical role within Regulatory Operations by preparing regulatory submission documents for final publishing and delivery to global health authorities. This position ensures that all documents meet technical, formatting, and eCTD (Electronic Common Technical Document) requirements prior to formal submission. The role partners closely with Regulatory Affairs, Medical Writing, CMC, Nonclinical, and Clinical teams to ensure high-quality, compliant, and timely regulatory submissions (e.g., INDs, NDAs, MAAs, amendments).

The ideal candidate has strong attention to detail, experience with document management and eCTD standards, and the ability to manage multiple concurrent submission activities in a fast-paced environment.

This role is based out of either our Cambridge, Ma or San Francisco, Ca office and may require up to 15% travel.

Your work will primarily encompass:

Document Preparation &amp; Formatting
<ul>
<li>Prepare and format submission-ready documents, including applying PDF standards, bookmarks, hyperlinks, headers/footers, and accessibility elements</li>
<li>Ensure all documents meet technical standards (e.g., PDF/A compliance, OCR/searchability, file size limits)</li>
<li>Verify that tracked changes, comments, draft watermarks, and metadata are removed before pre-publishing</li>
<li>Serve as a subject-matter expert for the Starting Point templates and provide training, guidance, and support to cross-functional teams on how to use these templates effectively</li>
</ul>
 Submission Assembly Support
<ul>
<li>Assist Regulatory Operations staff in assembling and preparing eCTD sequences for publishing</li>
<li>Coordinate with submission teams to confirm final document versions and readiness for publishing</li>
<li>Track and document issues, risks, and deviations, escalating as appropriate</li>
<li>Work closely with Regulatory Affairs, Medical Writing, CMC, Quality, and Clinical teams to ensure submission accuracy and completeness</li>
</ul>
Quality Control &amp; Compliance
<ul>
<li>Perform technical QC checks on documents prior to publishing, ensuring formatting, structure, and completeness</li>
<li>Develop publishing standards and guidelines in coordination with Regulatory Operations and Medical Writing</li>
<li>Ensure all pre-publishing activities comply with company SOPs, regulatory guidelines, and eCTD specifications</li>
</ul>
Ideal Candidate Profile &gt;&gt;&gt;

A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role.

Knowledge:
<ul>
<li>Bachelor's degree is required</li>
<li>Knowledge and experience of eCTD submissions</li>
<li>Knowledge and experience with enterprise document management systems, preferably Veeva RIM</li>
<li>Knowledge and understanding of global industry standards, guidelines, and validation concepts, including eCTD format and registration tracking</li>
<li>Experience with StartingPoint eCTD templates or equivalent</li>
</ul>
 Experience:
<ul>
<li>Minimum 3+ years pharmaceutical industry experience in Regulatory Affairs, Regulatory Operations or Medical Writing</li>
<li>Demonstrated leadership skills while working in a fast paced and changing environment</li>
<li>Experience in building and submission of NDA and life-cycle management is highly desirable</li>
</ul>
Attributes:
<ul>
<li>Displays strong proactive acumen and inclusive way of engagement to drive decision making, turnaround time improvement and effective ways of working</li>
<li>Influences the cross-functional team to adapt fit-for purpose solutions to meet the expected timelines</li>
<li>Ability to understand, analyze and develop recommendations from multiple complex sources such as scientific and operational perspectives
</li><li>Excellent written and verbal communication skills</li>
<li>Excellent negotiation and organizational skills</li>
</ul>
The base pay range for this position is expected to be $145,000 - $155,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits.

#LI-CK1<div>
Important Information &gt;&gt;&gt;
We provide equal opportunity to all employees and applicants for employment and believe that great ideas and discoveries come from a mix of expertise, background, and experience. Olema is building a culture where the value of difference is celebrated.

We offer a competitive compensation and benefits package, seeking to provide an open, flexible, and friendly work environment to empower employees and provide them with a platform to develop their long-term careers. A Summary of Benefits is available for all applicants.

Please note: Olema doesn't accept agency resumes and is not responsible for any fees related to unsolicited resumes. Thank you.

Fraud Alert: We are aware of employment scams where individuals pose as representatives of Olema Oncology and make false use of our company name to defraud job seekers. To protect yourself, please note that Olema's official email addresses end in @olema.com. Our official corporate website is olema.com; our careers page is olema.com/careers; our LinkedIn page is linkedin.com/company/olema-oncology. Please visit these links for official information from Olema. Communication from any other variant is fraudulent. Olema does not conduct interviews via text message/messaging platforms, will not ask you to download anything as part of your interview, will never request any form of payment, provide upfront payments of any kind, and does not make job offers without an in-person interview.</div></div>

Submission Content Manager, Regulatory Affairs Operations

Amgen

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

Regulatory Affairs "Labelling" Manager| MEA

<div>HOW MIGHT YOU DEFY IMAGINATION? If you feel like you&rsquo;re part of something bigger, it&rsquo;s because you are. At Amgen, our shared mission&mdash;to serve patients&mdash;drives all that we do. It is key to our becoming one of the world&rsquo;s leading biotechnology companies. We are global collaborators who achieve together&mdash;researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It&rsquo;s time for a career you can be proud of. Join us.
Regulatory Affairs Senior Manager| MEA
Scope
Provides strategic leadership and oversight for labeling activities across MEA markets, ensuring regional alignment to Global Labeling Strategy and governance. Drives risk management, operational excellence, capability building, and timely patient access across diverse regulatory environments.
Key Responsibilities:<ul><li>
Define and maintain MEA regional labeling strategy and operational priorities across clusters/products, aligned to global governance and business priorities (launches, safety updates, lifecycle changes).</li><li>
Serve as the senior MEA labeling representative in global governance forums and labeling working groups; advocate for regional needs and enable timely global decisions.</li><li>
Provide strategic oversight and direction for complex labeling changes (e.g., safety‑driven updates, class labeling, multi‑market harmonization, shared pack strategy) and launch readiness .</li><li>
Lead and approve regional impact assessments for global core label changes; set implementation approach, timelines, and escalation pathways for high‑risk updates.</li><li>
Accountable for inspection readiness: ensure compliant processes, robust documentation/traceability, audit support, and timely closure of observations/CAPAs related to labeling and packaging controls.</li><li>
Drive continuous improvement, standardization, and efficiency across MEA labeling processes (e.g., templates, playbooks, KPI frameworks, quality checks) to improve predictability and reduce rework.</li><li>
Provide leadership for vendor and partner performance (e.g., translation agencies, artwork houses) including quality expectations, service levels, and continuous improvement actions (budget oversight where applicable).</li><li>
Ensure effective cross‑functional coordination across Regulatory, Safety, Quality, Supply Chain, and affiliate teams to maintain supply continuity and patient access.</li><li>
People leadership: recruit/structure resources as needed, coach and develop L5/junior team members, set objectives, conduct performance reviews, and build succession and capability plans.</li><li>
Acts as escalation point for labeling risks, delays, and Health Authority interactions that threaten compliance, supply continuity, or patient safety.</li><li>
Influences global and regional stakeholders to align decisions, trade‑offs, and implementation timelines.</li></ul>
Qualifications:<ul><li>
Bachelor&rsquo;s degree in pharmacy or related life sciences (required); advanced degree preferred.</li><li>
Typically, 8&ndash;10+ years of Regulatory Affairs experience with demonstrated regional or global labeling leadership.</li><li>
Current or previous experience within MNCs is a must.</li><li>
Proven strategic thinking, governance participation, and risk management capability across complex, multi‑country portfolios.</li><li>
Language skills: English (required); French literacy strongly preferred; additional regional languages an advantage.</li><li>
Demonstrated people leadership (coaching, performance management) and ability to influence without authority across matrix teams.</li></ul>
Thrive What You Can Expect Of Us As we work to develop treatments that take care of others, so we work to care for our teammates&rsquo; professional and personal growth and well-being. 
<ul><li>
Vast opportunities to learn and move up and across our global organization</li><li>
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act</li><li>
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits</li></ul>
Apply now for a career that defies imagination In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us. 
 
careers.amgen.com Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, gender, sexual orientation, gender identity, national origin, protected veteran status, or disability status.</div>

Regulatory Affairs Senior Manager| MEA

SkyBlue

<div>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.
Key Responsibilities
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.</li></ul>
Soft Skills:<ul><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)

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