- AbbVie (North Chicago, IL)
- …(https://www.tiktok.com/@abbvie) . Job Description The Senior Manager Regulatory Affairs, Chemistry, Manufacturing and Controls ( CMC ) works with internal ... and external partners to deliver products to patients. Prepares CMC regulatory strategies that enable first pass approvals. Develops and manages content strategy… more
- Otsuka America Pharmaceutical Inc. (Columbus, OH)
- Provide CMC regulatory strategy input and expertise in the area of investigational, new and marketed biologic and small molecule drug products to assigned ... drug manufacturing processes, GMP and related issues. + Knowledge of CMC regulatory requirements for biologics and small molecules during development and… more
- Gilead Sciences, Inc. (Foster City, CA)
- …create possible, together. **Job Description** **Responsibilities** + The Regulatory Affairs CMC Senior Manager at Gilead is responsible for providing ... strategic direction, tactical support, and technical expertise for CMC regulatory activities and related regulatory initiatives. + Responsible for guiding… more
- Amgen (Holly Springs, NC)
- … Site Team is responsible for input to the development and implementation of CMC regulatory strategies and activities for products manufactured at or planned for ... manufacturing, testing (QC/QA or clinical), or distribution in Pharmaceutical/Biotech industry + Regulatory CMC experience + Ability to develop solutions to… more
- Vera Therapeutics (Brisbane, CA)
- Title: Senior Manager , Early-Stage Biologics Development, CMC Location: Brisbane, CA About Us: Vera Therapeutics (Nasdaq: VERA), is a late clinical-stage ... medical treatment for patients suffering from immunological diseases. Position Summary: The Senior Manager , Early-stage Biologics Development, CMC will be… more
- The US Pharmacopeial Convention (USP) (Rockville, MD)
- …inclusive and collaborative work environment. **Brief Job Overview** The ** Senior Manager , Chemical Manufacturing and Controls ( CMC ) Technical Advisor** is a ... promote engaged, collaborative, and results-driven work environments. **The Senior Manager , Chemical Manufacturing and Controls ( CMC ) Technical Advisor** has… more
- Bristol Myers Squibb (Indianapolis, IN)
- …aims to be the global leader in radiopharmaceuticals. **Position Summary** The Manager ( Sr . Scientist), Radiopharmaceuticals will be responsible for advancing ... processes. . Author technical reports and source documents to support regulatory filing. . Author CMC sections for IND/NDA for FDA submissions, 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 About Us: Vera Therapeutics (Nasdaq: VERA), is a late clinical-stage biotechnology… more
- Merck (Rahway, NJ)
- …within the business. Working independently, the Protocol Clinical Supplies Project Manager (Protocol CSPM) designs strategic and operational plans for all activities ... process & connectivity between functions supporting pipeline (ie clinical development, CMC , supply chain, & human health), and balancing needs of patients… more
- Gilead Sciences, Inc. (Foster City, CA)
- …**Biologics Pivotal & Commercial Formulation and Process Development** , as an ** Sr .** **Associate Scientist** . The successful candidate will contribute to the ... documentation practices. + Author technical documents such as protocols, reports, regulatory dossier, etc. and prepare data-focused presentations for internal and… more
- Sumitomo Pharma (Columbus, OH)
- …are currently seeking a dynamic, highly motivated, and experienced individual for the position of ** Senior Manager , Regulatory Affairs** . The Senior ... Manager is part of the Global Regulatory Affairs (GRA) team based in the US and...the global regulatory lead (GRL) and the CMC regulatory lead in the formulation of… more
- Grifols Shared Services North America, Inc (Research Triangle Park, NC)
- …+ The successful candidate will form strong partnerships with the CMC organisation, ensuring the appropriate development, manufacturing, and testing processes of ... assets are of the highest quality and compliant with regulatory requirements. + The GPL will build team effectiveness...budgets and timelines in close collaboration with the Project Manager (PM) assigned from the PMO. + The GPL… more
- Otsuka America Pharmaceutical Inc. (Columbus, OH)
- The Sr . Manager , CTA Regulatory Strategy is responsible for providing critical support in developing global regulatory strategy, planning, and execution ... and within established budgets + Work collaboratively with members of the global regulatory team (GRL, Clinical Transparency, Medical Writing, GRA- CMC , etc.) to… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …duties as required. **Additional Responsibilities, Knowledge, Skills and Abilities:** + Global Regulatory CMC Experience is preferred. + Ability to work ... to act as a team member in the product manager area of Regulatory Affairs (Biopharma) supporting...team. **Additional Responsibilities, Knowledge, Skills and Abilities:** + Global Regulatory CMC Experience is preferred. + Ability… more
- Otsuka America Pharmaceutical Inc. (Columbus, OH)
- …business units as needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling, medical writing, ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription… more
- Vera Therapeutics (Brisbane, CA)
- Title: Senior Manager , Process Development, Downstream Location: Brisbane, CA About Us: Vera Therapeutics (Nasdaq: VERA), is a late clinical-stage biotechnology ... treatment for patients suffering from immunological diseases. Position Summary: The Senior Manager , Process Development, Downstream will be responsible for… more
- Bausch Health (Bridgewater, NJ)
- …aspects of product development team for agency filing + Work with the Pharmaceutical Regulatory Brand Senior Manager to make certain all product ... it-where your skills and values drive our collective progress and impact. The Senior Specialist Regulatory Affairs executes on the pharmaceutical regulatory … more
- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- **Job Summary** **The Senior Manager ,** **GPV Compliance & Business Management will support the** **leads of Global PV** **Audit & Inspection readiness** ... but not limited to the planning and** **conducting** **readiness activities/training.** **As the** ** Sr . Manager for audits and inspection** **, support the GPV… more
- Gilead Sciences, Inc. (La Verne, CA)
- …Sciences La Verne Engineering Project Management Office (PMO) is seeking a ** Senior Manager , Project Management New Product Line Manufacturing - Labeling** ... Packaging, Quality Assurance (QA), Quality Control (QC), Validation, Supply Chain, Regulatory / CMC , EHS, Finance, IT, and Engineering. **Project Team… more
- Gilead Sciences, Inc. (Foster City, CA)
- …and help create possible, together. **Job Description** **Key Responsibilities** Senior Manager , Global External Manufacturing Biologics supports uninterrupted ... external contract manufacturing network, while ensuring compliance with cGMP, regulatory requirements, and environmental, health, and safety legislations. This… more
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