- Lilly (Philadelphia, PA)
- …make life better for people around the world. Responsibilities: The Associate / Manager, CMC Regulatory and IMP Manufacturing Operations is a hybrid role within ... the two functional areas. The Associate / Manager is responsible for CMC regulatory operations, CMC change management, and document lifecycle management… more
- Boehringer Ingelheim (Ridgefield, CT)
- …and competitive advantage lie with our people. The Associate Director, US Product CMC Regulatory Affairs is responsible for the coordination and execution of ... marketing reports per US FDA regulations. The Associate Director, US Product CMC Regulatory Affairs acts as primary internal contact for all US regulatory… more
- Lilly (Philadelphia, PA)
- …support communities through philanthropy and volunteerism. **Position Overview:** The Manager - CMC Regulatory is responsible for the preparation and delivery of ... high-quality CMC regulatory submissions. This position supports Lilly/Avid diagnostic radiopharmaceutical marketed products globally. **Responsibilities:** +… more
- Merck (North Wales, PA)
- …in pharmaceutical or combination product research, development and/or manufacturing + Experience with CMC regulatory where drug is the primary mode of action ... a Director, the Associate Principal Scientist is responsible for implementing regulatory strategies for our organization in accordance with domestic and… 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
- Amgen (New Albany, OH)
- … 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
- Lilly (Indianapolis, IN)
- … CMC technical knowledge and regulatory science expertise to drive regulatory CMC strategies and develop submissions for marketing authorizations for the ... development strategies and submission content + Makes risk-based decisions on CMC regulatory strategies impacting product submissions across geographies and… more
- Lilly (Indianapolis, IN)
- …life better for people around the world. Lilly is looking for post approval regulatory CMC scientists to join us in delivering life-changing new medicines to ... technical knowledge and regulatory science expertise to drive regulatory CMC strategies and develop post approval and lifecycle regulatory strategies… more
- Gilead Sciences, Inc. (Foster City, CA)
- …responsible for providing strategic direction, tactical support, and technical expertise for CMC regulatory activities and related regulatory initiatives. + ... Responsible for guiding and overseeing the preparation of complex regulatory CMC submissions for investigational and commercial products with solid scientific… more
- Lilly (Indianapolis, IN)
- …manages the scientific and regulatory efforts of the team, overseeing CMC regulatory activities for global submissions and interactions with regulatory ... + Ensures department has broad technical knowledge and expertise in global CMC regulatory requirements and guidelines for conducting clinical trials, obtaining… more
- Lilly (Indianapolis, IN)
- … CMC technical knowledge and regulatory science expertise to drive regulatory CMC strategies and develop submissions for marketing authorizations for the ... development strategies and submission content + Makes risk-based decisions on CMC regulatory strategies impacting product submissions across geographies and… more
- Gilead Sciences, Inc. (Foster City, CA)
- … candidate to sit at our Foster City, CA site. **Responsibilities:** + The CMC Regulatory Affairs Associate Director at Gilead is responsible for providing ... strategic direction, operational support, and technical expertise for CMC regulatory activities and related regulatory initiatives + Responsible for… more
- AbbVie (North Chicago, IL)
- …works with internal and external partners to deliver products to patients. Prepares CMC regulatory strategies that enable first pass approvals. Develops and ... teams to negotiate, influence, and provide strategic advice. Responsibilities: + Prepares CMC regulatory product strategies. Prepares and manages regulatory … more
- Orchard Therapeutics (Boston, MA)
- …business priorities. This role represents a unique opportunity to contribute to Regulatory CMC activities supporting maintenance and development of Orchard's ... products in clinical development: . Participate in definition and implementation of Regulatory CMC strategy for assigned program(s). . Collaborate with Technical… more
- Organon & Co. (Jersey City, NJ)
- … strategies. Prepare and review of information required for development of Regulatory CMC dossiers for projects and products including clinical development, ... for assigned products across the product lifecycle. Identify and communicate potential regulatory issues to company's Regulatory CMC management, as… more
- BeiGene (Harrisburg, PA)
- …seeking an experienced and instrumental regulatory professional to lead US biologics regulatory CMC team. This individual leads biologics regulatory ... based in China and cross-functional stakeholders in developing and executing biologics regulatory CMC strategies, oversees CMC -related regulatory … more
- Takeda Pharmaceuticals (Boston, MA)
- …knowledge. **Job Description** **OBJECTIVE / PURPOSE** + Providesprogram leadership and develops CMC regulatory strategy in support of global vaccine programs in ... CMC regulations and guidelines by applying interpersonal skills and expert regulatory CMC knowledge to identify, communicate, address, and overcome challenges… more
- Eurofins (Indianapolis, IN)
- … development strategies and submission content. + Makes technical decisions on CMC regulatory issues impacting product submissions across geographies, with ... support or guidance from Client GRA- CMC regulatory scientists. + Provide high quality, timely and clear regulatory advice to allow CMC teams to make… more
- Gilead Sciences, Inc. (Washington, DC)
- …Join Gilead and help create possible, together. **Job Description** The Director, CMC Regulatory Affairs Policy, Advisory and Intelligence is part of ... in developing and advocating policy positions (internally and externally) in the CMC regulatory sphere. The role will be focused on the North American policy… more
- Vera Therapeutics (Brisbane, CA)
- …Development in project teams. * Prepare, review, or edit cGMP batch records, CMC regulatory and quality documents. Qualifications: * PhD/MS in relevant life ... trials. In addition, the role requires authoring, reviewing, and editing of CMC related regulatory submissions and associated quality documents. The candidate… more
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