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 a leader to manage a team of CMC experts in Norwood, MA, overseeing regulatory correspondence and applications, shaping product strategy, and guiding regulatory activities to produce high-quality CMC sections for submissions. You will lead interactions...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 Role:The Associate Director, Global Regulatory-CMC will be responsible for coordinating regulatory CMC activities for one or more products,... ...will be responsible for developing global regulatory CMC strategies and collaborating with key stakeholders to execute the strategies...SuggestedPermanent employmentFull timeWork at officeWork from home$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...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...SuggestedMinimum wageTemporary workLocal areaRemote workWorldwide$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- ...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...
- ...CRISPR. Reporting to the Head of Regulatory Affairs, you will work... ...patients. As the Regulatory CMC lead for these programs, you... ...implement innovative Regulatory strategies where little precedent exists... ...accomplishments: ~ Associate Director: ~12+ Years of relevant experience...Contract workRemote work
$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$195k - $330k
...inclusivity, so that our people are valued, seen, and heard.How you’ll make an impact:Lead the development and execution of global regulatory CMC strategies for degrader programs across all stages of development, from early-stage activities through late-stage development and...$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- Moderna, in the United States, seeks an Associate Director, Global Regulatory-CMC to coordinate regulatory CMC activities across product lifecycles, develop global strategies, and guide product teams toward compliant submissions. You will lead interactions with health...
$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- ...an experienced and energetic Associate Director, Regulatory Affairs to join our Regulatory Affairs... ...help shape and execute global regulatory strategy, lead submission planning and execution... ..., including clinical, nonclinical, and CMC activities. Develop and implement...Local area
$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$163.5k - $281.6k
...work that truly matters for patients, we invite you to join us. Responsibilities Develop and implement comprehensive global regulatory CMC strategies for assigned gene therapy programs, including IND/CTA, BLA/MAA, and post-approval submissions. Lead and manage the...Full timeFor contractorsWork at officeFlexible hours- 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$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...$174.5k - $274.23k
...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 wageTemporary workLocal areaRemote workWorldwide$200k - $220k
Director/ Senior Director, Regulatory CMC Join Us in Tackling Autoimmune Disease at Its Root At Vor, we believe science can do more than manage symptoms... ...career in science, clinical development, commercial strategy, and beyond. Innovation: Work on a platform with...Contract workWorldwideFlexible hours$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- 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
$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$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- Vertex is seeking an Executive Director of Regulatory Strategy to lead global regulatory efforts for its Type 1 Diabetes portfolio. You will guide senior cross-functional teams, shaping strategy and liaising with health authorities while driving program leadership and staff...
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