- Merck (Rahway, NJ)
- …career. The Executive Director , Chemistry, Manufacturing & Controls ( CMC ), Pre-approval Pharm will bring scientific and regulatory expertise, innovative ... member in executive forums, driving the development and implementation of CMC regulatory strategy and plans for assigned projects/products. + Effectively… more
- Lilly (Philadelphia, PA)
- …and advance care for patients with unmet needs. **Position Overview:** The Associate Director , CMC Development will be responsible for the execution of multiple ... Process Development, Analytical Sciences, Manufacturing, Quality, Supply Chain, R&D, Finance, and Regulatory to ensure delivery of CMC milestones for priority… more
- Orchard Therapeutics (Boston, MA)
- Location: Boston, MA Main responsibilities The Executive Director (ED) Regulatory Science will actively support, and serve as senior advisor to, the program ... collaborate with the assigned US Regulatory lead, their peers in Europe, the Regulatory CMC team and the VP of Regulatory Science, to ensure a consistent… 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
- Lilly (Indianapolis, IN)
- …drug development experience for 10 years + Direct experience in clinical and CMC regulatory sciences + Experience in applicable therapeutic area + Knowledge ... around the world. **Purpose:** The purpose of the Senior Director , Global Regulatory Affairs, Global Regulatory...affiliate requirements. The GRL builds and leads the Global Regulatory Team (inclusive of GRA central functions, GRA- CMC… more
- 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
- Gilead Sciences, Inc. (Foster City, CA)
- …than 35 countries worldwide, with headquarters in Foster City, California. ** Executive Director , Global Clinical Supply Chain (GCSC)** **KEY RESPONSIBILITIES:** ... Executive Director , Global Clinical Supply Chain is responsible for leading...clinical labeling, distribution including cold chain, import/export, reverse logistics, CMC and GXP regulations. + Prior experience in complex… more
- Boehringer Ingelheim (Ridgefield, CT)
- …We are seeking a seasoned legal professional to join our Legal Department as Executive Director & Executive Counsel - Intellectual Property. This role ... provides strategic legal counsel to senior leadership (VP, EVP, CMC , and Level 1 executives), with a focus on intellectual property (IP) acquisition, due diligence,… more
- CSL Behring (King Of Prussia, PA)
- …position and is onsite three days a week. You will report to the Executive Director Head Regulatory . **Position Description** **Summary** * Regulatory ... connects and maintains relationships with GRAST members, including GRAS Regions and Regulatory CMC . *Applies the CSL Leadership Capabilities - Build Bridges,… 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
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