- 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
- Regeneron Pharmaceuticals (Troy, NY)
- …with the Health Authority. **A typical day might include:** + Oversee the assigned CMC /CP Regulatory Affairs team, driving global regulatory strategies ... strategies for the assigned drug/device portfolio. This role involves overseeing regulatory affairs staff, various outside contractors, supporting project teams… 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 ... empower you to shine? Join us as a Senior Manager of Statistics- CMC in our Cambridge,...as appropriate in a timely manner. + Respond to regulatory questions that are statistical in nature. + Increase… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …with 5+ years' experience or Master's degree with 2 years' experience in regulatory affairs or related areas (eg, clinical development, project management, ... needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling,...the global regulatory team (GRL, regional leads, CMC -RA, labeling, medical writing, regulatory operations, etc.)… more
- BD (Becton, Dickinson and Company) (Warwick, RI)
- …but not limited to healthcare antiseptic products. Under the mentorship of the Sr. RA Manager of Regulatory Affairs , they are responsible for the development ... **Job Description Summary** The Senior Regulatory Affairs (RA) Specialist within the...requirements and support the proposed product claims. + Review CMC changes and determine regulatory reporting category… more
- Parexel (Des Moines, IA)
- …country-specific regulatory requirements. * Act as key partner to GRA Regions, Regulatory CMC and Supply Chain. Qualifications: * University degree in Life ... Join us as a **Global Labeling Operations Manager ** , where you'll work alongside a large,...AU) and non-US/Central EU markets, ensuring compliance with global regulatory requirements and supporting cross-functional teams in delivering accurate,… more
- CSL Behring (King Of Prussia, PA)
- …successful regulatory outcomes. Effectively partner with assigned product/s Global Regulatory Affairs Strategy Team (GRAST) GRL plus other regional, labeling ... connects and maintains relationships with GRAST members, including GRAS Regions and Regulatory CMC . + Proactively fosters and promotes effective relationships… more
- Bristol Myers Squibb (Princeton, NJ)
- …projects. + Identifies issues or is assigned projects that will impact BMS, regulatory affairs or projects and provides strategies for dealing with them. ... preferred. + 8-12 years pharmaceutical industry experience, including 6-8 years in regulatory affairs . Global experience strongly preferred with command of US… more
- Boehringer Ingelheim (Duluth, GA)
- …vision or to improve collaboration. The stakeholders will vary from USA GI Region, USA CMC , Corporate Affairs or regulatory agencies. + In partnership with ... Operations Excellence Partner is to partner with the USA Regulatory Affairs team in executing key strategic...initiatives to achieve USA priorities for RA and USA CMC objectives. This role is directly responsible for improving… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …by closely working with MTP internal colleagues in various functions (Quality Assurance, Regulatory Affairs , Marketing, Market Access, Medical Affairs , Drug ... effectively with colleagues in Supply Chain, Accounting, Market Access, Quality Assurance, Regulatory Affairs , Finance, etc. of Tanabe Pharma Group, including… more
- Bristol Myers Squibb (Madison, NJ)
- …Stability, Analytical Development, Process Development, Manufacturing Sciences and Technologies, Regulatory Affairs , and other Cell Therapy Development ... QA, QC, analytical and process development, manufacturing sciences and technology, and regulatory affairs functions. + Supports the overall product quality… more
- AbbVie (Irvine, CA)
- …brands (Development, Discovery, Development Sciences, Operations, Commercial, Market Access, Regulatory , Safety, Project Management, Medical Affairs , etc., and ... Asset Plan and PDP, tracking progress in conjunction with the Portfolio Project Manager , with attention to committed timeline and budget. + Ensures that the AST… more
- ThermoFisher Scientific (Greenville, NC)
- …deliverables + Advanced, broad understanding of global/regional/national country requirements/ regulatory affairs procedures for clinical trial authorization, ... in the Con Mod process. + Communicates with People Manager (s) to support the development of the employee providing...global regulatory guidelines; in-depth understanding of a regulatory specialty areas, such as preclinical, clinical, CMC… more
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