- AbbVie (Waltham, MA)
- …. 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
- Gilead Sciences, Inc. (Foster City, CA)
- …of Regulatory Affairs Associate II, CMC sits in Gilead's CMC Regulatory Affairs - Small Molecule Group. Responsibilities and qualifications are ... plans. Shadows leads while they develop and execute robust CMC regulatory strategies. + Under the guidance...manager support. + Invests in acquiring knowledge about CMC regulatory intelligence including guidelines and … more
- Kelly Services (Winston Salem, NC)
- **Job Title: Manager , Regulatory CMC (Contractor)** **Hourly Pay Rate: $62.50** **Schedule: Monday-Friday, 9:00 AM-5:00 PM (Must work Eastern Time hours)** ... Remote** **Position Summary:** An advanced therapy biotech organization is seeking a ** Manager , Regulatory CMC (Contractor)** to provide specialized support… more
- Sanofi Group (Morristown, NJ)
- …with the M&S Hubs supporting the technical writing function. + Collaborate closely with Global Regulatory Affairs (GRA) CMC to align on dossier strategies. + ... **Job Title:** Manager , CMC Development and Dossiers **Location**...content generation for reports leading to the authoring of CMC dossier content for regulatory submissions and… more
- Abeona (Cleveland, OH)
- …achieve commercialization and capacity expansion objectives. + Collaborate with Clinical Operations, Regulatory , Medical Affairs , CMC , Biometrics, and other ... We are seeking a highly skilled and driven Senior Manager of Project Management to lead and drive strategic...working with technical operations or similar groups and has CMC experience within the pharmaceutical or biotech industry. The… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …The purpose of this position to act as a team member in the product manager area of Regulatory Affairs (Biopharma) supporting global submissions for various ... Specialist I_** **Primary responsibilities for role:** + Act as Regulatory Affairs representative for specified key products/facilities/equipment. + Prepare… more
- Otsuka America Pharmaceutical Inc. (Bismarck, ND)
- …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
- Bausch Health (Bridgewater, NJ)
- …and values drive our collective progress and impact. The Associate Director, Regulatory Affairs handles regulatory development and post-approval/ ... assigned pharmaceutical products. + Coordinate/Liaise with BHC country-specific pharmaceutical Regulatory Affairs personnel for international submissions and… more
- Veterans Affairs, Veterans Health Administration (Tucson, AZ)
- …support provided relieves the Service Line Manager , Supervisory Program Specialist, RN Manager and Midlevel providers in the CMC Service Line of routine ... making daily assignments for the MSAs and receives little guidance from the manager . The lead MSA makes assignments by defining the overall objectives, priorities,… more
- Haleon (Richmond, VA)
- …communication skills. **Preferred Qualifications:** + Knowledge of GMP, BOH, and Regulatory Affairs regulations and guidelines + Analytical and laboratory ... uniquely ours. Care to join us. It isn't a question. The **QA Manager ** leads Quality and Compliance activities for assigned product projects during the development… more