- 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
- 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
- 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
- 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
- Pfizer (Groton, CT)
- …+ Bachelor's and 4+ years of experience or Master's degree in Life Sciences, Regulatory Affairs , Data Management, or related field and 2+ years of experience ... for initial registrations. They work in close collaboration with Regulatory Strategy, CMC Leads, Clinical, Non-Clinical, RIO...with Master's + 4+ years of experience in Regulatory Affairs or Regulatory Operations,… 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
- Actalent (Lake Forest, CA)
- Description We are seeking an experienced and strategic Regulatory Affairs Manager to support global regulatory submissions and compliance activities. ... Test plan, Regulatory compliance, Compliance, Quality engineering, Medical device, Regulatory affairs , CMC , manufacturing controls, RAC certification, e… more
- Pfizer (Groton, CT)
- …: + Bachelor's and 6+ years of experience or Master's degree in Life Sciences, Regulatory Affairs , Data Management, or related field. + 5+ years of experience in ... ** Regulatory , Data Steward & Team Lead (Sr. Manager )** Vault RIM process and system is highly dependent... Regulatory Affairs or Regulatory Operations… 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
- AbbVie (Barceloneta, PR)
- …to use their broad understanding of Product Development, Manufacturing, Quality and Regulatory Affairs to translate the business objectives into actionable ... with experience in drug substance and/or drug product transfers. The program manager is to provide strategic oversight for one or more industrialization programs,… 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
- 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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