- 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 (Boston, MA)
- …with functional areas from quality, process experts, product experts, device experts, and regulatory affairs . + Works with supervisor for alignment on project ... application is true to the best of my knowledge. **Job Description** **Title: CMC Project Manager ** **Location: Cambridge, MA (Hybrid)** **About the role:** As… 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
- ThermoFisher Scientific (Grand Island, NY)
- …Chemistry, or related field; advanced degree preferred + 7 years of experience in CMC regulatory affairs within the pharmaceutical industry + 1+ year ... Practices (GMP) Safety Standards, Office **Job Description** The Sr. Manager , Regulatory Affairs - Drug...regulatory standards + Provide strategic mentorship on applicable CMC regulatory submissions and support for customers… more
- Otsuka America Pharmaceutical Inc. (Atlanta, GA)
- …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
- 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
- BeOne Medicines (Emeryville, CA)
- …role provides compliance oversight and guidance across Regulatory Operations, Regulatory Affairs , Quality, Safety/Pharmacovigilance, Clinical, CMC , and ... **General Description** **:** The Manager , Regulatory Compliance Programs reports to the Senior Director of Regulatory Compliance and is responsible for… 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 Mitsubishi Tanabe Pharma Group,… more
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