Director of Regulatory CMC Strategy
$224.9k - $404.6kModerna
Moderna is seeking a regulatory CMC expert to manage a team at their Norwood, MA site. This key leadership role involves overseeing the product strategy for all portfolio products, managing regulatory submissions, and ensuring adherence to quality standards. Ideal candidates will have over 10 years in the pharma/biotech industry, with strong knowledge of US and international regulations. The position offers a competitive salary range of $224,900 - $404,600, along with excellent benefits for a holistic approach to employee well-being. #J-18808-Ljbffr Moderna
- 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...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- BioSpace is seeking a qualified individual to manage a team of CMC experts at its Norwood, MA site. The role involves developing and implementing effective CMC regulatory strategies, overseeing regulatory submissions, and ensuring compliance with health authority guidelines...Suggested
$224.9k - $404.6k
...MA site and will be responsible for managing a team of CMC experts that prepare and oversee CMC and quality related agency correspondence and regulatory applications. This position will oversee the product strategy for all the products in their portfolio and lead and support...SuggestedPermanent employment- 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...Suggested
$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...$142.5k - $256.5k
Associate Director, Global Regulatory-CMC The Associate Director, Global Regulatory-CMC will coordinate regulatory CMC activities for one or more... ...across their lifecycle, develop global regulatory CMC strategies, collaborate with stakeholders to execute strategies in...Permanent employment$142.5k - $256.5k
Role Overview The Associate Director, Global Regulatory-CMC will coordinate regulatory CMC activities for one or more products throughout their lifecycle, develop global regulatory CMC strategies, collaborate with stakeholders, and manage multiple projects to support the...- Takeda in Boston, MA seeks a Director of Regulatory Site CMC to lead post‑approval change management across multiple sites, guiding submissions and... ...regulatory activities. You will communicate regulatory strategy to drug development, registration, and post‑market teams,...
$238k - $374k
...changing therapies to patients worldwide. As Executive Director, Global Regulatory Affairs CMC Early Development you will provide strategic... ...to ensure innovative, robust, fit‑for‑phase regulatory strategies for small molecule and biologic products for FIH to pre...Full timeTemporary workLocal areaWorldwide- ...pipeline. This individual will work closely with the CMC, Quality Assurance, Clinical Drug Supply, and Regulatory Affairs teams to ensure the successful planning, development, and delivery of CMC regulatory strategy across programs. The ideal candidate brings deep expertise...Flexible hours
$189k - $246k
...Department: 107000 Regulatory Location: San Diego, USA- Remote Position Summary The Director, Regulatory Affairs Strategy is responsible for developing and executing global regulatory... ...Operations, Medical Affairs, Biostatistics, CMC, Quality, Nonclinical, Commercial, and...Temporary workLocal areaRemote workWeekend work- ...seeking an experienced and commercially minded Senior Director or Executive Director of US Regulatory Strategy to join our growing regulatory consulting... ...strategy, expedited pathways, regulatory risk assessment, CMC, nonclinical and clinical requirements, labeling, and...
- Takeda is seeking an Executive Director for Global Regulatory Affairs CMC Early Development in Boston, MA. This leadership position involves strategic management of global CMC regulatory strategies for small molecules and biologics, from FIH to pre-pivotal development....
$238k - $374k
...changing therapies to patients worldwide. As Executive Director, Global Regulatory Affairs CMC Devices and Drug‑Device Combination Product, you will... ...experts to ensure innovative and robust regulatory strategies for medical devices and drug‑device combination products...Minimum wageFull timeTemporary workWork at officeLocal areaRemote workWorldwide$170k - $220k
...Associate Director, Regulatory CMC – Solid Biosciences Charlestown, MA HQ Solid Biosciences is a precision genetic medicine company focused on... ...in program teams and bridges CMC development and regulatory strategy. We are seeking an Associate Director of Regulatory Strategy...Full timeTemporary workRemote workFlexible hours- .... About the Role This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to... ...follows: Independently develops the regulatory CMC strategy and leads the execution of regulatory CMC...Full timeLocal areaWorldwide
- ...seeking an experienced and strategic Director of Regulatory Affairs to lead and support global regulatory... ...developing and executing regulatory strategies that support global product... ...and immunology background is preferred. CMC experience is a plus. Responsibilities...
- Takeda in Boston, MA seeks a Senior Director and Regulatory Platform Lead focusing on GRA CMC, Human Factors for drug-device combinations. You will guide global regulatory strategies across device and pharmaceutical development, ensuring high-quality filings and right-...
$187.5k - $275k
...medicines for serious diseases. Regulatory affairs collaborates cross... ...building successful regulatory strategies. Verve is located in Boston,... ...Responsibilities The Senior Director, Regulatory Affairs is responsible... ...clinical, nonclinical, and CMC regulatory strategy including...Full timeWork at officeFlexible hours3 days per week$210k - $235k
...science, clinical development, commercial strategy, and beyond. Innovation: Work on a... ...across functions and geographies. The Director, Regulatory Strategy provides global regulatory leadership... ...partner to R&D, Clinical, Quality, CMC, Commercial, and represents the...Remote workWorldwideFlexible hours$190k - $215k
...about this opportunity as we are! Your Impact As Associate Director, Regulatory Strategy, you'll help define the regulatory path for our small-... ...advise to cross-functional team members including clinical, CMC, clinical pharmacology, and nonclinical Accountable for the...Full timeWork at officeLocal areaImmediate start$211.5k - $258.5k
Job Summary The Director, Regulatory Strategy - Global Regulatory Lead is responsible for developing and leading the integrated global regulatory strategies... ...all assigned programs, ensuring alignment with clinical, CMC, and non-clinical development activities and overall...Local areaFlexible hours2 days per week- Senior Manager/Associate Director, Global Regulatory Affairs CMC About the Opportunity A growing biotechnology company is seeking an experienced Senior... ..., Global Regulatory Affairs CMC to support regulatory strategy and execution across the development and commercialization...
$174.5k - $274.23k
A leading biopharmaceutical company is seeking a Director Regulatory Site CMC in Boston, MA. The role focuses on regulatory change control and post... ...background in global HA requirements and regulatory strategy. This hybrid position offers a competitive salary range between...- ...Inc. is seeking a seasoned professional for a role in Global Regulatory Affairs, focusing on Chemistry Manufacturing & Controls. The successful candidate will lead the development of regulatory CMC strategies and manage submissions critical to product lifecycle. Applicants...
$177k - $278.08k
...bring life-changing therapies to patients worldwide. The Director Regulatory Site CMC ensures efficient and compliant management of regulatory change... ...a proven ability to understand and communicate regulatory strategy to drug development, registration, and post‑market support...Minimum wageFull timeTemporary workLocal areaRemote workWorldwide- Associate Director / Director, Global Regulatory Affairs CMC About the Opportunity A growing biopharmaceutical organization is seeking an experienced Regulatory... ...Affairs CMC professional to lead global regulatory strategy and execution across development, registration, and...
$150k - $195k
...Diego, USA - Remote Position Summary The Associate Director, Technical Operations CMC Strategy is responsible for the creation and execution of the... ...This individual will collaborate closely with Quality, Regulatory Affairs, Clinical, and Supply Chain to ensure alignment...Contract workTemporary workRemote work$212k - $333.19k
About the role As Senior Director and Regulatory Platform Lead GRA CMC, Device and Drug-Device Combinations Human Factors, you will provide leadership for... ...pure device and combination product regulatory strategies particularly pertaining to the development, registration...Minimum wageTemporary workLocal areaRemote workNight shift
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