- Otsuka America Pharmaceutical Inc. (Albany, NY)
- 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
- 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
- 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
- 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
- Sumitomo Pharma (Frankfort, KY)
- …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
- 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
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- The Sr. Manager , CTA Regulatory Strategy is responsible for providing critical support in developing global regulatory strategy, planning, and execution of ... and within established budgets + Work collaboratively with members of the global regulatory team (GRL, Clinical Transparency, Medical Writing, GRA- CMC , etc.) to… more
- Otsuka America Pharmaceutical Inc. (Montgomery, AL)
- …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
- 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
- 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
- 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
- The US Pharmacopeial Convention (USP) (Rockville, MD)
- …tools to promote engaged, collaborative, and results-driven work environments. _The Senior Manager , Verification Programs has the following responsibilities:_ * ... guideline on the Common Technical Document (CTD) for pharmaceuticals, and/or regulatory Chemistry, Manufacturing Controls ( CMC ) submission experience. * Detail… more
- Integra LifeSciences (Plainsboro, NJ)
- …new treatment pathways to advance patient outcomes and set new standards of care. The ** Senior Project Manager ** is a key member of the value stream leadership ... team for Integra's Collagen Manufacturing Center ( CMC ) in Plainsboro, NJ. Reporting to the assigned value stream manufacturing manager , this position is… 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** ... limited to the planning and** **conducting** **readiness activities/training.** **As the** **Sr. Manager for audits and inspection** **, support the GPV Audit &… more
- Integra LifeSciences (Plainsboro, NJ)
- …pathways to advance patient outcomes and set new standards of care. The Senior Manager , Manufacturing is responsible for plant production activities for ... CMC (Collagen Manufacturing Center). This includes assigning and monitoring...minimum costs, prevent operational delays, and maintain quality and regulatory compliance standards. + Trains and ensures all assigned… more
- BMO Financial Group (New York, NY)
- …**Mandate** : Vice President will work directly with the Director, Regulatory & Financial Crisis Management (OCOO) to be accountable for: Preparing ... for and executing regulatory examinations or reviews of Capital Markets legal entities...as directed + Interact directly, and in coordination with senior management, with key regulators as required + Help… more
- AbbVie (North Chicago, IL)
- …early-stage pipeline. This will be in collaboration with our CMC team, CMC Product Development Director, and Delivery System Senior Leadership. Your role ... . Job Description AbbVie is seeking an Associate Project Manager to drive the execution and oversight of projects...will manage product development timelines and scopes to support CMC gate reviews and clinical phase plans. Collaboration with… more
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