Global Regulatory CMC Director: Strategy & Submissions
Discover International
Discover International is seeking an experienced Associate Director / Director in Global Regulatory Affairs CMC to lead regulatory strategy and execution. This role involves developing CMC strategies for complex pharmaceutical products and guiding major submissions. The ideal candidate will have over 10 years of experience in the biopharmaceutical industry, a strong background in regulatory submissions, and the ability to influence cross-functional teams. Join a collaborative environment with opportunities for growth and strategic impact. #J-18808-Ljbffr Discover International
$177k - $278.08k
JobRx, Inc. is seeking a Regulatory Affairs professional in Boston, MA to manage regulatory CMC strategy for pharmaceutical products. The role requires 10+ years of experience... ...with a strong focus on leading major submissions and ensuring regulatory compliance. This position...Suggested- ...pharmaceutical company is looking for a Director of Regulatory Affairs to provide strategic and... ...The candidate will prepare regulatory submissions, interact with health authorities like... ...role is vital for supporting ongoing global clinical studies. #J-18808-Ljbffr Noema...Suggested
- 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...Suggested
$224.9k - $404.6k
Initial Therapeutics, Inc. is seeking a CMC Regulatory Manager based in Norwood, MA. The role involves leading a team of CMC experts to develop and implement regulatory strategies, ensure submission readiness, and manage interactions with health authorities. Ideal candidates...Suggested- Takeda in Boston, MA seeks a Director of Regulatory Site CMC to lead post‑approval change management... ...across multiple sites, guiding submissions and aligning with global regulatory expectations. You... ...You will communicate regulatory strategy to drug development, registration...Suggested
- ...Pharmaceuticals is seeking an Associate Director, Global Submission Management in Boston to lead a portfolio of global regulatory submissions across development and lifecycle... ...You will partner with Global Regulatory Strategy, CMC, Labeling, Publishing, and Advertising &...
- JobRx, Inc. is looking for a Director to define and lead global regulatory strategies in Boston, MA. The ideal candidate will manage the Global Regulatory Teams... ...with regulatory requirements, and oversee all FDA submissions. The role demands strong leadership, extensive...
- 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...
- Merck is seeking an Executive Director of Chemistry, Manufacturing, and Control for Biologics to manage CMC professionals and ensure compliance with global regulatory strategies. This senior role involves overseeing submissions for high-quality CMC for biologics products...
- Hemab Therapeutics is seeking a Director of Regulatory Affairs to develop and execute global regulatory strategies for rare hematologic disorders. You will lead complex submissions, guide cross-functional teams... ...strong background in global CMC regulatory requirements,...
$211.5k - $258.5k
Job Summary The Director, Regulatory Strategy - Global Regulatory Lead is responsible for developing and leading... ...pre-IND planning, IND/CTA submission strategy, Phase I/II/III development... ..., ensuring alignment with clinical, CMC, and non-clinical development activities...Local areaFlexible hours2 days per week$238k - $374k
...patients worldwide. As Executive Director, Global Regulatory Affairs CMC Early Development you will provide... ...robust, fit‑for‑phase regulatory strategies for small molecule and biologic products... ...CMC regulatory strategy and key submissions/health authority interactions for...Full timeTemporary workLocal areaWorldwide- ...Inc. is seeking a seasoned professional for a role in Global Regulatory Affairs, focusing on Chemistry Manufacturing &... ...successful candidate will lead the development of regulatory CMC strategies and manage submissions critical to product lifecycle. Applicants must hold a...
- ...Role This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and... ...develops the regulatory CMC strategy and leads the execution of regulatory... ...of global registrational submissions of complex drug product or...Full timeLocal areaWorldwide
- Vertex Pharmaceuticals Inc is seeking a Director, Global Submission Management (GSM) to provide strategic oversight and execution of global regulatory submissions across development and... ...submissions aligned with global regulatory strategies. It requires leadership across...
- Vertex Pharmaceuticals in Boston seeks a Director, Global Submission Management to lead global regulatory submissions across development and... ...lifecycle programs, aligning with regulatory strategies and coordinating with Strategy, CMC, Labeling, Publishing, and Advertising...
$196.7k - $353.4k
...seeking an individual to lead development and execution of global regulatory strategy for programs in its oncology portfolio. This leader will... ...development through commercialization Drive regulatory submissions (INDs, CTAs, BLAs/MAAs) with excellence and urgency Lead...Permanent employment$238k - $374k
...patients worldwide. As Executive Director, Global Regulatory Affairs CMC Devices and Drug‑Device Combination... ...innovative and robust regulatory strategies for medical devices and drug‑device... ...regulatory strategy and major submissions for an assigned portfolio of medical...Minimum wageFull timeTemporary workWork at officeLocal areaRemote workWorldwide- ...Rosa Therapeutics, Inc is seeking a Director of Regulatory Affairs based in Boston. This... ...developing and executing regulatory strategies to support global product development, particularly... ...the ability to manage regulatory submissions and work with health authorities such...
- ...Chemistry, Manufacturing and Controls (CMC) regulatory strategy for development and lifecycle... ...manufacturing, quality and regulatory to prepare submissions and respond to regulatory requests.... ...ability to influence the global internal/external regulatory environment...Work at officeLocal areaRemote workWorldwide
$196.7k - $353.4k
...biotechnology firm in Cambridge, Massachusetts, is seeking a seasoned regulatory leader to drive global regulatory strategy for their oncology portfolio. Responsibilities include leading regulatory submissions, health authority interactions, and developing high-performing...- AstraZeneca GmbH in Boston, MA is seeking a Director of Regulatory Affairs Strategy for Cell Therapy to lead global regulatory strategy across oncology, immune-mediated... ...You will drive Health Authority engagements, submissions, and labeling, mentor cross-functional teams,...
$212k - $333.19k
Takeda is seeking a Senior Director to define and lead global regulatory strategies in Boston, MA. This role requires over 12 years of experience in the pharmaceutical... ...industry, with a strong emphasis on regulatory submissions and compliance. The ideal candidate will have...- Initial Therapeutics, Inc. is seeking a Senior Director to lead global regulatory strategies in Boston. This role requires extensive experience in regulatory... .... This position includes responsibilities for FDA submissions and cross-functional collaboration to ensure project...
- Vertex is seeking a Regulatory Strategy Senior Director based in Boston. You will lead the development and execution of global and regional regulatory strategies for development programs... ...franchise strategy and successful submissions. The role may be global, regional or...Local area
$211.5k - $258.5k
BioSpace is seeking a Director, Regulatory Strategy to manage global regulatory strategies for early-stage programs in immunology and inflammation. This hybrid role requires expertise in FDA and EMA submission processes and leading regulatory interactions. Qualifications...- ...Pharmaceuticals Incorporated in Boston, MA, is seeking a Regulatory Strategy Associate Director to oversee the global regulatory strategy for development programs and... ..., advising teams, and ensuring compliance of submissions. Vertex offers a hybrid work model and a...
$245k - $300k
Merida Biosciences in Cambridge, MA is seeking a Sr. Director, Regulatory Affairs to lead and execute global regulatory strategies. The ideal candidate will oversee health authority interactions, regulatory submissions, and strategic guidance for innovative therapeutics....- Takeda is looking for a Director, Global Regulatory Lead Oncology in Boston, MA. This role encompasses setting the global regulatory strategy and overseeing all regulatory activities for high... ...teams to ensure timely and quality submissions to the FDA and other agencies....
$177k - $278.08k
...changing therapies to patients worldwide. Join Takeda as Director, Global Regulatory Labeling Strategy where you will be responsible for the development and... ...respective functions. Labeling Documents Authoring, Submission, and Labeling Negotiations Independently authors new...Full timeTemporary workLocal areaWorldwide
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