Associate Director, Global Regulatory Affairs CMC Lead
USA - 3316 Takeda Development Center Americas, Inc.
Takeda's Global Regulatory Affairs - CMC team in Cambridge, MA is seeking a Regulatory CMC professional to lead regulatory submissions for investigational, registration and post-approval programs across global markets.
With minimal supervision, you will define CMC content, develop regulatory strategies, collaborate with cross-functional teams and Health Authorities, and ensure regulatory compliance with Takeda procedures and global requirements.
#J-18808-Ljbffr$154.4k - $242.55k
...therapies to patients worldwide.This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute... ...follows: With minimal supervision, develops and leads the execution of regulatory CMC investigational,...SuggestedMinimum wageLocal areaRemote workWorldwide- ...patients worldwide. This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to... ...follows: With minimal supervision, develops and leads the execution of regulatory CMC investigational,...SuggestedWorldwide
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The Role Moderna is looking for an Associate Director, Global Regulatory Affairs, CMC, to join our team. This pivotal role will focus on preparing and overseeing... ...of global products. The successful candidate will lead and support all regulatory activities, ensuring the...Permanent employmentWork at officeLocal areaWork from home- ...Galderma in Boston, MA is seeking an Associate Director, Global R&D Compliance Lead to oversee the R&D compliance program, manage GFRC, and advise on investigator-initiated studies, regulatory changes, and training across a global, matrixed organization. This role requires...
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...will play a key role in regulatory strategy development... ...Manufacturing and Control (CMC) programs. Your Role:... ...accountable for developing and leading the execution of... ...and execute CMC global submission plans and timelines... ...CMC and regulatory affairs leads/SMEs.Independently...$166.4k - $249.6k
...DescriptionGeneral Summary:The Chemistry Manufacturing Controls (CMC) Associate Director leads and executes global regulatory CMC strategies across investigational and... ...in Biology, Chemistry, Pharmacy, Regulatory Affairs, or related life science field (advanced degree preferred...Full timeSummer workRemote workFlexible hours2 days per week- Biogen, Inc. in Cambridge, MA (hybrid) seeks a CMC Commercial Asset Development Lead to guide asset strategy, development, supply, and lifecycle planning... ..., strategic decision making, and collaboration with global teams across IND to NDA/BLA processes, enabling Biogen’s...
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...DescriptionGeneral Summary:The Associate Director, CMC Quality Compliance and... ...forumsKnowledge and Skills:Knowledge of regulatory requirements and inspection... ...or leanProven ability to lead improvement projects and... ...InformationVertex is a global biotechnology company that...Full timeSummer workRemote workFlexible hours2 days per week$154.4k - $242.55k
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...Associate Director, Global Regulatory Affairs At Kailera, we are bold, authentic and committed to our mission of... ...late phase investigational products, leading the writing and submission of IND/... ...team members including Regulatory CMC and Regulatory Operations to ensure...Full timeLocal areaFlexible hours$190k - $210k
...Associate Director, Global Regulatory Affairs, Compliance Responsibilities Translate applicable laws, regulations, and guidance into practical regulatory compliance strategies supporting development and business objectives. Support high-quality, timely execution of regulatory...Flexible hours$153.6k - $241.34k
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...Associate Director, Global Regulatory Affairs ComplianceOlema Oncology is a clinical-stage biopharmaceutical company committed to transforming the standard... ...company well underway, top-line data from our lead program expected later this year, and our first potential...Work at officeFlexible hours2 days per week- ...Associate Director, Global Regulatory Affairs, Advertising and Promotion Job Description At Takeda, we are a forward‑looking, world‑class R&D organization... ...Affairs Advertising and Promotion (GRA A&P) Review Lead is accountable for management of all assigned programs...Full timeRemote workWorldwide
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