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
- Moderna is seeking aRegulatory CMC Senior Leader based in Norwood, MA to manage a team of CMC experts overseeing regulatory correspondence and submissions. You will steer product strategy across portfolio and drive regulatory activities for high-quality CMC sections. You...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$224.9k - $404.6k
...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 be required to oversee the product strategy for all the products in their portfolio and lead...SuggestedPermanent employmentFull timeWork at officeWork from home$142.5k - $256.5k
The RoleThe Associate Director, Global Regulatory, CMC will be responsible for coordinating regulatory CMC activities for one or more products, depending... ...be responsible for developing global regulatory CMC strategies and collaborating with key stakeholders to execute the...SuggestedPermanent employmentFull timeWork at officeWork from home- ...is seeking a Chemistry Manufacturing Controls Manager to lead regulatory CMC activities for both investigational and commercial products. The role involves reviewing CMC sections, developing global strategies, and coordinating with cross-functional teams to ensure...Suggested
$154.4k - $242.55k
...patients worldwide.This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute... ...investigational, registration and/or post-approval strategies for assigned products. RA CMC member on the...Minimum wageTemporary workLocal areaRemote workWorldwide$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...$238k - $374k
...to the best of my knowledge.Job DescriptionExecutive Director, Global Regulatory Affairs CMC Early DevelopmentAre you looking for a patient-focused... ...to deliver innovative, compliant global CMC regulatory strategies and submissions for small molecule and biologic products...Minimum wageTemporary workLocal areaRemote work$238k - $374k
...changing therapies to patients worldwide.As Executive Director, Global Regulatory Affairs CMC Devices and Drug-Device Combination Product, you will... ...matter experts to ensure innovative and robust regulatory strategies for medical devices and drug-device combination...Minimum wageTemporary workWork at officeLocal areaRemote workWorldwide$190.4k - $285.6k
Job DescriptionGeneral Summary:The Director, Chemistry Manufacturing Controls (CMC) leads a Regulatory CMC team responsible for developing and executing global regulatory strategies across multiple investigational and commercial products in the small molecule portfolio...Full timeSummer workRemote workFlexible hours2 days per week$180k - $245k
...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.ResponsibilitiesDevelop...$218.06k - $327.09k
Job Title: Senior Director, Regulatory Affairs Strategy - Cell Therapy Available locations: Gaithersburg, MDBoston, MASouth San Francisco, CASanta Monica... ...and aligning regulatory objectives with clinical, CMC, safety and commercial strategies.Evidence and Decision-Making...Hourly payFull timeTemporary workStart working todayWork at officeFlexible hours3 days per week$166.4k - $249.6k
Job DescriptionGeneral Summary:The Chemistry Manufacturing Controls (CMC) Associate Director leads and executes global regulatory CMC strategies across investigational and commercial products focusing on biologics. This role is accountable for authoring, reviewing, and...Full timeSummer workRemote workFlexible hours2 days per week$163.5k - $281.6k
...invite you to join us. Eli Lilly and Company is seeking a highly experienced and strategic Director/Senior Director, Regulatory CMC to lead and execute regulatory CMC strategies for our cutting-edge gene therapy portfolio. This role will be critical in shaping the regulatory...For contractorsWork at officeFlexible hours$182k - $275k
...Opportunity OverviewThis role is responsible for executing high-quality, science-based, and compliant regulatory CMC deliverables for assigned program(s), in alignment with strategies established by Global Regulatory Affairs and Technical Operations.This individual contributor...Work at office- Associate Director, Regulatory Affairs CMC (Project Management) Job Description Company Overview Founded over a decade ago,CRISPR Therapeuticsis... ...opportunity to devise and implement innovative Regulatory strategies where little precedent exists. You will work in close...Contract workRemote work
- Responsibilities: The Associate Director, Regulatory Affairs CMC will be responsible for leading regulatory CMC activities for Anagram’s portfolio... ...all stages. Assist with developing Regulatory-CMC strategies and collaborating with key stakeholders to execute the strategies...
$212.85k - $354.75k
...Overview This strategic leadership role is accountable for defining the future direction of CMC regulatory submissions and ensuring alignment between regulatory strategy, development data strategies, and global enterprise initiatives. The role will lead CMC Regulatory...Full timeLocal area2 days per week$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$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- Lilly is seeking an experienced Regulatory CMC leader to develop and implement global CMC strategies for gene therapy programs. You will lead the preparation of CMC sections for IND/CTA, BLA/MAA submissions and serve as the primary liaison with major health authorities...
$242k - $313.5k
Senior Director, Regulatory Affairs CMC - Biologics About Beeline Medicines: Beeline Medicines is a clinical‑stage biotechnology company focused... ...responsible for developing and executing biologics CMC regulatory strategies from early clinical development through BLA filing and...Local area2 days per week- ...bring life‑changing therapies to patients worldwide. The Director, Regulatory Site CMC ensures efficient and compliant management of regulatory... ...proven ability to understand and communicate regulatory strategy to drug development, registration, and post‑market support...Local areaWorldwide
$276k - $414k
Job Title: Executive Director, Regulatory Affairs Strategy - Cell Therapy Available locations: Gaithersburg, MDBoston, MASouth San Francisco, CASanta Monica, CAIntroduction to role: Are you ready to set the global regulatory direction for first-in-class cell therapies and...Hourly payFull timeTemporary workWork at officeWorldwideFlexible hours3 days per week$268.2k - $402.2k
Job DescriptionGeneral Summary:The Executive Director, Regulatory Strategy will serve as a seasoned regulatory leader with expert technical and tactical regulatory knowledge and advanced drug development expertise in Type 1 Diabetes (T1D). The incumbent will be responsible...Full timeSummer workLocal areaRemote workFlexible hours2 days per week$232k - $348k
Job DescriptionThe Regulatory Strategy Senior Director is a regulatory leader with expert technical and tactical experience in regulatory strategy for the assigned global or regional position and will be responsible for overseeing the development and implementation of advanced...Full timeSummer workWork at officeLocal areaRemote workFlexible hours2 days per week3 days per week- Job DescriptionGeneral Summary:The Regulatory Labeling Director will lead the strategic development of global labeling on one or more marketed products... ...) for select markets (e.g., US, EU, GB, CA).Lead labeling strategy with expert ability to advise stakeholders of regulatory...Full timeSummer workWork at officeLocal areaRemote workFlexible hours2 days per week
$212k - $333.19k
...changing therapies to patients worldwide. As Senior Director and Regulatory Platform Lead GRA CMC, Device and Drug‑Device Combinations Human Factors, you... ...pure device and combination product regulatory strategies particularly pertaining to the development, registration...Minimum wageFull timeTemporary workLocal areaWorldwideNight shift$200k - $265k
...unparalleled, direct impact.The OpportunityLeads the global regulatory strategy, submission planning, and health authority engagement for Nemolizumab... ...and documents, including clinical, non-clinical, and CMC development documentation as neededQualificationsKnowledge and...Full timeTemporary workWork experience placementWork at officeWorldwide- A biotech company is seeking a Senior Director of Regulatory Affairs for a fully remote role. This position involves leading regulatory strategy and compliance for early-stage drug development. The ideal candidate will have over 10 years of experience in regulatory affairs...Remote work
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