Global CMC Regulatory Lead | Strategy & Submissions
SoTalent
SoTalent seeks a Senior Manager, Global Regulatory Affairs (CMC) to drive regulatory strategy and submissions for clinical development and post-approval. The role collaborates with development, QA, analytical, and manufacturing teams, ensuring alignment with global requirements and company strategy. The ideal candidate has 6+ years in regulatory affairs, strong experience with IND/NDA/BLA submissions, and a proven ability to manage cross-functional programs in a regulated environment. #J-18808-Ljbffr SoTalent
- ...seeking an experienced Associate Director / Director in Global Regulatory Affairs CMC to lead regulatory strategy and execution. This role involves developing CMC... ...complex pharmaceutical products and guiding major submissions. The ideal candidate will have over 10 years of...Regulatory
- A global pharmaceutical company seeks a Regulatory Affairs Specialist in Boston, MA. The role involves developing regulatory strategies for prescription drug submissions and managing lifecycle activities. Candidates should have a Bachelor's with 5+ years in regulatory affairs...Regulatory
- ...(US) is seeking an Associate Director for Global Submission Management to oversee strategic global regulatory submissions across development and lifecycle... ...submissions aligned with global regulatory strategies. The role leads cross‑functional teams, manages submission...Regulatory
$170k - $220k
A genetic medicine company in Boston is seeking an Associate Director of Regulatory CMC to lead regulatory strategy and bridge development with regulatory roles. This hybrid position requires strong regulatory affairs experience in biotechnology, excellent communication...Regulatory- ...thing. Position Summary You will lead Chemistry, Manufacturing, and Controls (CMC) regulatory strategy and execution for mature... ...compliance with FDA expectations and global standards. Prepare and review... ..., with a focus on IND and BLA submissions to the FDA. Experience as a...RegulatoryLocal area
- Moderna seeks an Associate Director, Global Regulatory-CMC in Norwood, Massachusetts. This role involves coordinating regulatory CMC activities and developing strategies for transformative medicines. The ideal candidate will have at least 8 years in the biotech space,...Regulatory
- A global healthcare firm is seeking a Regulatory CMC Lead in Boston, MA. The role requires expertise in regulatory strategy, operations, and planning for CMC aspects of assigned projects. Candidates... ...for ensuring successful product submissions and regulatory compliance. #J-1880...Regulatory
- GlaxoSmithKline is looking for a professional to lead CMC regulatory strategy in Cambridge, Massachusetts. The role involves working across teams to support timely access to medicines and ensure compliance with regulatory standards. Candidates should have a Bachelor’s...Regulatory
- Takeda in Boston, MA, seeks an experienced Regulatory CMC professional to lead submission planning and execution for clinical and post‑marketing programs. You will work with global teams to align regulatory strategy with product development goals. The role emphasizes regulatory...Regulatory
$211.5k - $258.5k
Job Summary The Director, Regulatory Strategy - Global Regulatory Lead is responsible for developing and leading the... ...pre-IND planning, IND/CTA submission strategy, Phase I/II/III development... ...ensuring alignment with clinical, CMC, and non-clinical development activities...RegulatoryLocal areaFlexible hours2 days per week- ...Katalyst CRO in Boston is seeking a Regulatory Affairs professional to lead CMC strategies for investigational products. The candidate will interact with Health Authorities and manage regulatory submissions to ensure compliance and success. With a foundation in regulatory...Regulatory
- ...Senior Manager/Associate Director for Global Regulatory Affairs CMC in Boston, MA. This key position involves supporting regulatory strategy and execution for innovative... ...regulatory frameworks. You will lead global regulatory submissions and collaborate with cross-functional...Regulatory
- A public Biotech company in Boston is seeking a Regulatory Affairs CMC Manager/Senior Manager to support biologic products' global development and registration. The ideal candidate will lead the submission of regulatory documentation, ensuring compliance with FDA and EMA...Regulatory
- A leading biotechnology firm in Boston is seeking a Regulatory Strategy Manager to oversee global regulatory activities for investigational products. This role includes preparing regulatory submissions, guiding the team on responses, and supporting NDA submissions. Ideal...Regulatory
- ...Inc. in the United States is seeking a Global Submission Manager to oversee global submission... ...portfolio. You will represent GRO on Global Regulatory Teams, coordinate submission planning,... ...Associates, drive digital submission strategies, and act as SME during audits and...Regulatory
- Relay Therapeutics in Cambridge, MA is seeking a motivated regulatory professional to join their dynamic team. You will support innovative regulatory strategies and manage global submissions including IND, CTA, NDA, and MAA. The ideal candidate has a B.S./M.S. with 2+ years...Regulatory
- Meet Life Sciences is seeking a Director / Senior Director, Global Regulatory Lead in Boston, MA to drive regulatory strategy across oncology programs. The ideal candidate will lead NDA submissions and collaborate with various teams, leveraging over 10 years of regulatory...RegulatoryWork at officeRelocation package
- ...Pharmaceuticals in Boston is seeking a Regulatory Strategy Associate Director responsible for overseeing global and regional regulatory... ...with major health authority submissions. This role offers the... ...potential bonuses, and market-leading benefits. #J-18808-Ljbffr Vertex...Regulatory
- Parexel in Boston seeks a Regulatory Affairs Consultant/Senior Consultant to lead regulatory efforts for a... ...client. You will guide global clinical development through regulatory strategy, health authority... ...authority interactions, submission planning, and compliance...Regulatory
- ...biopharmaceutical company in Boston is seeking a Regulatory Affairs Specialist to coordinate the preparation of regulatory submission packages. The ideal candidate will have at... ...drugs, and a strong understanding of CMC requirements. Key responsibilities include managing...Regulatory
- Mass Digital Health is seeking a Global Regulatory Lead to develop and execute innovative regulatory strategies across its product portfolio. Based in either Morristown, NJ, or Cambridge, MA, this role is vital to ensure compliance with industry standards while advocating...Regulatory
- A leading pharmaceutical company in Cambridge is seeking a Senior Director, Global Regulatory Lead for GI & Inflammation. This role is critical in ensuring compliance and securing... ...lead multiple teams and oversee all FDA submissions, driving strategic regulatory initiatives...Regulatory
$193k - $210k
...pharmaceutical firm in Cambridge, MA seeks a Senior Regulatory Affairs Manager to lead the development and execution of regulatory strategies throughout the product lifecycle.... ...alignment with clinical plans and incorporating global Health Authority feedback. This role offers...Regulatory$209.35k - $258.6k
Akebia Therapeutics is seeking a Director of Regulatory Labeling in Cambridge, MA. This key role involves leading global labeling strategies across product life cycles and ensuring compliance with regulatory standards. The ideal candidate will have 10+ years of pharmaceutical...Regulatory- Medella Life is looking for a Director of Regulatory Affairs to spearhead regulatory strategy for rare disease programs in Cambridge, MA. This role involves leading regulatory submissions and acting as the primary interface with health authorities like the FDA. The ideal...Regulatory
- Allergan is seeking a Director of Regulatory Affairs to develop and implement global regulatory strategies to secure product approvals. The role involves leading the Global Regulatory Product Team and requires strong leadership experience within the pharmaceutical sector...Regulatory
$160k - $240k
Rhythm Pharmaceuticals Inc. is seeking a Global Regulatory Lead in Boston, Massachusetts. This position involves developing regulatory strategies, leading filings, and communicating with health authorities. The ideal candidate will have over 8 years of regulatory experience...Regulatory- Beeline Medicines in Boston is seeking a Director of Regulatory Strategy to lead the global regulatory strategies for early-stage and pipeline programs in the immune and inflammation (I&I) therapeutic area. The role requires at least 10 years of regulatory experience,...Regulatory
- BioSpace is seeking an Associate Director, Global Regulatory-CMC in Norwood, Massachusetts. This role involves coordinating regulatory activities and developing CMC strategies for product lifecycles. Candidates should possess a PhD in a relevant field and a minimum of...Regulatory
- ...Therapeutics is seeking an Associate Director for Technical Operations CMC Strategy to oversee the execution of CMC strategy across a diverse... ...experience in CMC strategy, ensuring alignment with Quality, Regulatory, Clinical, and Supply Chain. Role involves leadership in...RegulatoryRemote work
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