- 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 project ... **Job Description** + Anticipate and develop strategies and/or contingency plans for CMC related scenarios in the areas of biologic/small molecule drug substances,… more
- Amgen (New Albany, OH)
- The Regulatory Affairs CMC Site Team is responsible for input to the development and implementation of CMC regulatory strategies and activities for products ... manufactured at or planned for the specific site. The CMC site team interfaces with the site (R&D and...that may implicate a regulatory strategy or activity. The CMC site team are members of CMC … more
- Lilly (Indianapolis, IN)
- …the world. Lilly is looking for regulatory Chemistry, Manufacturing and Control ( CMC ) scientists to join us in developing and bringing life-changing new medicines ... over the world. We are seeking Regulatory Scientist GRA CMC -Parenteral Commercial Products to be a part of the...you will be expected to collaborate with the broader CMC team to provide strategic, tactical, and operational support… more
- Lilly (Indianapolis, IN)
- …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 patients who ... Advisor Post approval scientist in Global Regulatory Affairs - CMC Commercial Products will leverage CMC technical...Affairs - CMC Commercial Products will leverage CMC technical knowledge and regulatory science expertise to drive… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders. **Summary** CMC Lead is responsible for supporting the overall CMC strategies within ... project needs and the respective development stage of the project. The CMC Lead will support the Sr. CMC Lead on complex and/or late-stage project or act as main… more
- Sanofi Group (Waltham, MA)
- **Job Title:** CMC Project Manager **Location:** Framingham, MA, Waltham, MA **About the Job** Are you ready to shape the future of medicine? The race is on to speed ... be critical in helping our teams accelerate progress. The CMC Project Manager is a key contributor of the... Project Manager is a key contributor of the CMC Project Excellence department to provide a world class… more
- Eurofins (Indianapolis, IN)
- …strategies and submissions in support of clinical trials. This position utilizes CMC technical knowledge to drive internal consistency and influence effective change ... not limited to: + Leads preparation, technical, and regulatory review and finalization of CMC sections for global CTA submissions + Takes a proactive role in the… 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 and overseeing the… more
- Lilly (Philadelphia, PA)
- …life better for people around the world. Responsibilities: The Associate / Manager, CMC Regulatory and IMP Manufacturing Operations is a hybrid role within CMC ... functional areas. The Associate / Manager is responsible for CMC regulatory operations, CMC change management, and...Manager is responsible for CMC regulatory operations, CMC change management, and document lifecycle management within IMP… more
- BeiGene (Harrisburg, PA)
- …an experienced and instrumental regulatory professional to lead US biologics regulatory CMC team. This individual leads biologics regulatory CMC team based ... China and cross-functional stakeholders in developing and executing biologics regulatory CMC strategies, oversees CMC -related regulatory submissions and health… more
- Lilly (Indianapolis, IN)
- …people around the world. **Purpose:** The Senior Director of Global Regulatory Affairs - CMC (GRA- CMC ) leads and manages the scientific and regulatory efforts of ... the team, overseeing CMC regulatory activities for global submissions and interactions with regulatory authorities for Lilly's synthetic molecule portfolio. This… more
- Boehringer Ingelheim (Ridgefield, CT)
- …competitive advantage lie with our people. The Associate Director, US Product CMC Regulatory Affairs is responsible for the coordination and execution of regulatory ... US market product portfolio. These responsibilities include management of CMC and product labeling changes as well as the...per US FDA regulations. The Associate Director, US Product CMC Regulatory Affairs acts as primary internal contact for… more
- Takeda Pharmaceuticals (Boston, MA)
- …**Job Description** **OBJECTIVE / PURPOSE** + Providesprogram leadership and develops CMC regulatory strategy in support of global vaccine programs in various ... world-wide + Demonstrates leadership and comprehensive understanding of global vaccines CMC regulations and guidelines by applying interpersonal skills and expert… more
- Lilly (Indianapolis, IN)
- …the world. Lilly is looking for regulatory Chemistry, Manufacturing and Control ( CMC ) scientists to join us in developing and bringing life-changing new medicines ... all over the world. We are seeking Regulatory Scientist GRA- CMC to be a part of the Lilly global...you will be expected to collaborate with the broader CMC team to provide strategic, tactical, and operational support… more
- Gilead Sciences, Inc. (Foster City, CA)
- …together. **Job Description** We are seeking an Associate Director, Regulatory Affairs CMC candidate to sit at our Foster City, CA site. **Responsibilities:** + ... The CMC Regulatory Affairs Associate Director at Gilead is responsible...providing strategic direction, operational support, and technical expertise for CMC regulatory activities and related regulatory initiatives + Responsible… more
- Orchard Therapeutics (Boston, MA)
- …the Regulatory Team provide Regulatory and Chemistry, Manufacturing and Control ( CMC ) related expertise for development and commercial stage products, including ... priorities. This role represents a unique opportunity to contribute to Regulatory CMC activities supporting maintenance and development of Orchard's Cell & Gene… 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 a team ... stakeholders in developing and advocating policy positions (internally and externally) in the CMC regulatory sphere. The role will be focused on the North American… 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 ... immunological diseases. Position Summary: The Senior Manager, Early-stage Biologics Development, CMC will be responsible for all earlystage aspects of Drug Substance… more
- Lilly (Philadelphia, PA)
- …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...Responsible for the generation and execution of country specific CMC regulatory strategies + Author and review global … more
- AbbVie (North Chicago, IL)
- …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...areas, Operations, and Research & Development (R&D) organizations. Represents CMC on teams such as product development, Global Regulatory… more
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