- Sanofi Group (Morristown, NJ)
- …skills could be critical in helping our teams accelerate progress. The Manager , Global Regulatory Affairs - CMC has the responsibility of one or several ... root cause, sets-up corrective action plan and/or proposes alternate solutions. + Regulatory CMC Manager / PFP is independently responsible for reporting on… more
- Teva Pharmaceuticals (West Chester, PA)
- …make a difference with. **How you'll spend your day** Teva Pharmaceuticals USA Inc. seeks a Regulatory Affairs Manager in our West Chester, PA office to: + ... Manager , Regulatory Affairs Date:... Manager , Regulatory Affairs Date: Jun 3, 2025...Authority Applications (directly or indirectly) + Authoring and Reviewing CMC content for use in Health Authority Applications +… 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)
- …skills and values drive our collective progress and impact. The Senior Specialist Regulatory Affairs executes on the pharmaceutical regulatory strategies for ... team for agency filing + Work with the Pharmaceutical Regulatory Brand Senior Manager to make certain...Authorities for assigned brand products + Liaise with country-specific regulatory affairs personnel for international submissions and… 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
- Fresenius Medical Center (Knoxville, TN)
- …+ Experience in project management respectively change control process + Experience in regulatory affairs or in a quality environment, ideally in a ... to comply with regulatory requirements + Organization of submission-readiness of regulatory documentation (eg, CMC relevant parts) + Organize and support… more
- Vera Therapeutics (Brisbane, CA)
- …development programs. The Senior Manager will support both Clinical Regulatory and CMC activities. Responsibilities: * Proactively manage regulatory ... Title: Senior Manager , Clinical Regulatory Location: Brisbane, California...content that meets current regional requirements * Represent clinical Regulatory Affairs on cross-functional project teams *… 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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