- Merck & Co. (Rahway, NJ)
- Job DescriptionWe are looking for a Senior Specialist Regulatory Affairs CMC (m/w/d) to join our team in the innovative research location in Schwabenheim ... the corresponding documents and binders in Alexx submissions Supporting " senior " team member ( CMC AD) during LOQ-A...Project Coordination, Project Management, Quality Management, Regulatory Affairs Management, Regulatory CMC , … more
- Legend Biotech USA, Inc. (Philadelphia, PA)
- …and commercial strategy.Collaborate closely with internal functions such as Pharmacology, CMC , Regulatory Affairs , Clinical, and Program Management.Maintain ... in the treatment of multiple myeloma.Legend Biotech is seeking Sr . Director of Toxicology as part of the Clinical...Role OverviewWe are seeking a highly experienced and strategic Senior Director of Toxicology to lead and oversee all… more
- Insmed Incorporated (NJ)
- …both clinical and commercial supply chains.Your responsibilities will include supporting global CMC regulatory strategies that align with our clinical and ... will be vital as you partner with Discovery, Clinical Development, Quality, Regulatory Affairs , Operations, and Commercial teams to ensure seamless program… more
- Formation Bio (New York, NY)
- …to bring new treatments to patients faster and more efficiently.About the PositionThe Senior Director, Regulatory Affairs lead is responsible for developing ... INDs, NDAs/BLAs, CTAs, MAAs, supplemental NDAs/BLAs and other relevant regulatory filings. Provides Regulatory CMC ...preferred or equivalent relevant experience. Has 10-20 years of Regulatory Affairs experience as well as additional… more
- Astellas Pharma (Northbrook, IL)
- …remote work are encouraged to apply. **Purpose and Scope:** We are seeking an experienced CMC Regulatory Affairs Director with deep expertise in the United ... partners; with global health authorities at review, management and senior staff, including negotiations on controversial areas. Established rapport...MS preferred). + 10+ years of direct experience in CMC Regulatory Affairs within the… more
- Otsuka America Pharmaceutical Inc. (Augusta, ME)
- …discipline. + RAC certification will be a plus. **Experience** : + 7+ years in Regulatory Affairs CMC , with significant experience in small molecules is ... **Job Summary** The Chemistry, Manufacturing and Controls ( CMC ) Global Regulatory Affairs (GRA) professional is responsible for developing and executing… more
- AbbVie (North Chicago, IL)
- …. Job Description The Senior Manager Regulatory Affairs , Chemistry, Manufacturing and Controls ( CMC ) works with internal and ... policies and procedures. Analyzes and approves manufacturing change requests. + Represents CMC regulatory affairs on teams such as the product development,… more
- AbbVie (North Chicago, IL)
- …such as analytical, process engineering, internal and external manufacturing, quality assurance, CMC regulatory affairs , supply chain and Operations ... manner, independently or under the direction of a more senior scientific leader. This position will be an integral...+ Ability to influence internal and external experts on CMC regulatory issues, independently. + Demonstrated excellence… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …and biomarker assay development and validation. + Collaborate with Global Manufacturing, Regulatory Affairs , and Global Quality to explore methods and implement ... and empower you to shine? Join us as a Senior Manager of Statistics- CMC in our...as appropriate in a timely manner. + Respond to regulatory questions that are statistical in nature. + Increase… more
- Capgemini (New York, NY)
- …& Experience** **Skills & Experience (Required)** + **12+ years** in regulatory affairs ; direct leadership of **IND/NDA/BLA/MAA** submissions (10+ successful ... Capgemini Invent - LS Reg Affairs & Qlty - Sr Consultant...by technology created with purpose. **Your Role** As a Senior Consultant, you'll act as a **trusted regulatory… more
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