- Gilead Sciences, Inc. (Foster City, CA)
- …and help create possible, 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 for providing strategic direction, operational… more
- Merck (North Wales, PA)
- … Director position. Under direction from a Director , the Associate Principal Scientist is responsible for implementing regulatory strategies for our ... **Job Description** This Associate Principal Scientist position is equivalent to an...combination product research, development and/or manufacturing + Experience with CMC regulatory where drug is the primary… more
- Boehringer Ingelheim (Ridgefield, CT)
- …that our strength and competitive advantage lie with our people. The Associate Director , US Product CMC Regulatory Affairs is responsible for the ... and post marketing reports per US FDA regulations. The Associate Director , US Product CMC Regulatory Affairs acts as primary internal contact for all US… 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
- Lilly (Indianapolis, IN)
- …better for 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… more
- Bristol Myers Squibb (Indianapolis, IN)
- …to be the global leader in radiopharmaceuticals. **Summary** The Associate Director of Chemistry, Manufacturing & Controls ( CMC ) - Quality Assurance develops ... and drives Quality (manufacturing and analytical) strategies for CMC activities (drug substance, API, drug product, and analytics) for compounds in Development… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …project development preferred - 1 or More Years Extensive knowledge of global CMC regulatory requirement and preferably NDA or BLA/MAA submission experiences for ... areas centered around rare diseases and immune disorders. **Summary** CMC Lead is responsible for supporting the overall ...CMC Lead is responsible for supporting the overall CMC strategies within projects, and manage project teams. The… more
- Bausch Health (Bridgewater, NJ)
- …it-where your skills and values drive our collective progress and impact. The Associate Director , Regulatory Affairs handles regulatory development ... Participates on the product development/life-cycle management team to provide regulatory guidance for assigned pharmaceutical products. Primary focus on approved… more
- Otsuka America Pharmaceutical Inc. (Rockville, MD)
- **Job Summary** Associate Director , Quality Control, Biologics is responsible for late development stage through commercial biologic products including product ... Analytical Quality by Design. + Experience in reviewing and approving analytical-related CMC sections of BLA/MAA regulatory submissions. + Strong leadership,… more
- Merck (West Point, PA)
- **Job Description** We are seeking a highly motivated individual for the role of Associate Director , Biologics Drug Substance Lead within the Enterprise Go To ... Chain. The end-to-end scope includes Drug Substance for all large molecules. The Associate Director is expected to contribute to ongoing business process… more
- Taiho Oncology (Princeton, NJ)
- Associate Director , Product Development Princeton, NJ, USA Req #448 Thursday, March 6, 2025 Looking for a chance to make a meaningful difference in the oncology ... the oncology space this is the role for you. Position Summary: + The Associate Director , Product Development will be responsible for product development, scale… more
- Lilly (Indianapolis, IN)
- …scale-up/optimization for Ph3 and commercial launches. **Responsibilities:** The Assoc. Director of TS/MS enables Operational Excellence by ensuring strong ... agenda via the Commercialization Lead Team ensuring alignment and communication with CMC and Oncology Business Unit. + Benchmark and network with other Lilly… more
- Sanofi Group (Morristown, NJ)
- **Job title** : GRA Device Lead ( Associate Director ) **Location:** Cambridge. MA **,** Morristown, NJ **About the Job** Are you ready to shape the future of ... Sanofi portfolio of products. The team is part of the Global Regulatory Affairs, Regulatory CMC and Device Department within Global Research and Development.… more
- University of Southern California (Los Angeles, CA)
- cGMP Associate Director , Process DevelopmentApply (https://usc.wd5.myworkdayjobs.com/ExternalUSCCareers/job/Los-Angeles-CA Health-Sciences-Campus/cGMP- ... cell and gene therapies and other biological products for internal/external users. The Associate Director of Process Development (cGMP) is responsible for all… more
- AbbVie (North Chicago, IL)
- …/ week* This position can be hired based on the following qualifications below: Associate Director , Clinical Pharmacology: + PhD with typically 4+ years of ... groups to provide a unified clinical pharmacology position to clinical, CMC and regulatory teams. + Authors scientific publications and present at national and… more
- BeiGene (Emeryville, CA)
- **General Description:** The Associate Director , Clinical Pharmacology & Pharmacometrics will be responsible for developing and executing clinical pharmacology ... as well as cross-functional teams such as Clinical Development, Biometrics, Biomarkers, Regulatory , CMC etc. Responsibilities will include planning and reviewing… more
- Merck (Rahway, NJ)
- …process & connectivity between functions supporting pipeline (ie clinical development, CMC , supply chain, & human health), and balancing needs of patients ... a lead GCS Planning program representative) such as clinical development, regulatory , quality and other supply chain areas to negotiate timelines, strategies… more
- AbbVie (Worcester, MA)
- …process scientists, engineers, and statisticians to define data flows within the CMC organization. o Partner closely with Abbvie Business Data Systems/IT to deploy ... o Partner closely with Quality Assurance to ensure Biologics CMC data integrity practices are best in class. +...lab systems (eg PI, NuGenesis, IDBS) + Interactions with regulatory authorities (FDA, EMA) may be required. + Stay… more
- AbbVie (North Chicago, IL)
- …functional groups to provide a unified clinical pharmacology position to clinical, CMC and regulatory teams. + Authors scientific publications and present ... Pharmacology development plans and strategies that achieve commercial goals and regulatory requirements for multiple functions. Generates new PK/PD study proposals… more
- OnKure, Inc. (Boulder, CO)
- …development-stage biotech industry standards, and achieves desired compliance with regulatory , clinical, and business operations goals. The ideal Quality Assurance ... Assurance team to provide enhancements to Quality Systems to improve efficiency, regulatory compliance, and reduce manual processes Author and manage to resolution… more
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