- Lilly (Indianapolis, IN)
- …regulatoryaffairsand/ordrugdevelopmentexperiencefor 10years + Direct experience in clinical and CMC regulatory sciences + Experience in applicable ... around the world. **Purpose:** The purpose of the Senior Director Global Regulatory Affairs, Global Regulatory...affiliate requirements. The GRL creates and leads the Global Regulatory Team (inclusive of GRA central functions, GRA- CMC… more
- Orchard Therapeutics (Boston, MA)
- …closely collaborate with the assigned US Regulatory lead, their peers in Europe, the Regulatory CMC team and the VP of Regulatory Science, to ensure a ... Location: Boston, MA Main responsibilities The Executive Director (ED) Regulatory Science will actively...technical development of gene or cell-based therapies and associated regulatory CMC activities is not requested. .… more
- Amneal Pharmaceuticals (Piscataway, NJ)
- …and company goals and objectives. Essential Functions: + Develop and Execute Global Regulatory Strategies: Formulate and lead global CMC and clinical ... compliance with FDA, EMA, and Health Canada regulations. Assess regulatory impact of changes in CMC procedures...regulations. Assess regulatory impact of changes in CMC procedures and oversee internal regulatory guidance… more
- Boehringer Ingelheim (Ridgefield, CT)
- …liaison with the US Food and Drug Administration. * Research information on regulatory CMC standards and departmental policies. * Provide strategic regulatory ... resolution of comments from FDA with assistance from the Director /delegate CMC RA as needed. + NDA...and in collaboration with US RA Labeling Content, provide CMC regulatory support during Annual, CCDS, or… more
- CSL Behring (King Of Prussia, PA)
- …connects and maintains relationships with GRAST members, including GRAS Regions and Regulatory CMC . 7 For select roles with direct reports, mentors/coaches ... therapies that make a meaningful difference worldwide. Could you be our next Director Senior Global Regulatory Lead? The job is in our King of Prussia, PA or… more
- CSL Behring (King Of Prussia, PA)
- …connects and maintains relationships with GRAST members, including GRAS Regions and Regulatory CMC . *Applies the CSL Leadership Capabilities - Build Bridges, ... make a meaningful difference worldwide. Could you be our next Associate Director Global Regulatory Lead, EHT (Enabling Healthcare Technologies encompasses… more
- Lilly (Indianapolis, IN)
- …global regulatory climate and emerging requirements; ability to address key CMC regulatory questions that enable clinical studies and support marketing ... concept) to product commercialization + Experience in development / CMC including quality and regulatory interactions is...in development / CMC including quality and regulatory interactions is expected + Experience with technical transfer… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …alongside some of the brightest minds in Biopharma. **Position Summary** The Senior Director , Head of Potency and Impurity Assay Development (PIAD) reports to the ... of subject matter experts to orchestrate and execute, within the network, CMC potency and impurity strategy and structure-function understanding of product quality… more
- Bristol Myers Squibb (Devens, MA)
- …to ensure product quality, compliance and supply. + Author, review and approve regulatory CMC submission sections. + Drive continuous improvement initiatives to ... influencing external partnerships (CDMOs/CMOs) to achieve strategic outcomes. + Knowledge of CMC regulatory , drug substance & drug product manufacturing, and… more
- Gilead Sciences, Inc. (Foster City, CA)
- …& Manufacturing (PDM) and partner with Quality, Supply Chain, Manufacturing, CMC Regulatory Affairs, Clinical Development and Technical Development to ... Description:** **We are seeking a talented and highly motivated Director for our Structural Characterization team in Biologics Pivotal...deliverables. + Serve as an author and reviewer of CMC sections in regulatory filings, and support… more