- BeOne Medicines (San Mateo, CA)
- …assigned projects. The individual will provide support to cross-functional teams on CMC regulatory strategies and process optimizations on relevant topics. ... **Essential Functions of the job:** + Lead, develop and implement small molecule CMC regulatory strategies as well as authoring CTD CMC sections for the… more
- AbbVie (North Chicago, IL)
- …(https://www.tiktok.com/@abbvie) . Job Description The Associate Director Regulatory Affairs, Chemistry, Manufacturing and Controls ( CMC ) works with ... CMC development of peptides and sterile injectables. This individual prepares CMC regulatory strategies that enable first pass approvals. Develops and… more
- Boehringer Ingelheim (Ridgefield, CT)
- …currently seeking an Associate Director or Senior Associate Director to join our External Alternative CMC Development (EACD) department located at ... activities within the project(s), in support of CMC development within EACD. The Associate Director /Senior Associate Director of EACD for drug… more
- AbbVie (North Chicago, IL)
- …Tok (https://www.tiktok.com/@abbvie) . Job Description The Pharma Product Group Associate Director will be fully accountable for providing CMC leadership and ... issues is required. Ability to influence internal and external experts on CMC regulatory issues, independently. + Demonstrated excellence in writing,… more
- Lilly (Philadelphia, PA)
- …new medicines, and advance care for patients with unmet needs. **Position Overview:** The Associate Director , CMC Development will be responsible for the ... Process Development, Analytical Sciences, Manufacturing, Quality, Supply Chain, R&D, Finance, and Regulatory to ensure delivery of CMC milestones for priority… more
- AbbVie (North Chicago, IL)
- …external third parties. The primary function is to ensure consistent preparation of CMC regulatory submission documents of high scientific and technical quality ... strong negotiating, influencing, and leadership skills. + Manages completion of CMC regulatory submission documentation for multiple projects of moderate… more
- Organon & Co. (Jersey City, NJ)
- …**The Position** The Associate Principal Scientist ( Associate Director ) is responsible for developing and implementing Regulatory Chemistry, ... assigned products across the product lifecycle + Identify, communicate and escalate potential regulatory issues to Organon Regulatory CMC management, as… more
- Takeda Pharmaceuticals (Boston, MA)
- …is true to the best of my knowledge. **Job Description** **About the role:** As a CMC Lead, Small Molecules ( Associate Director ), you will be responsible for ... to the world. **How you will contribute:** + Provide strong direction to CMC Leads to drive effective life cycle management for Takeda's commercial small molecule… 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
- CSL Behring (King Of Prussia, PA)
- …therapies that make a meaningful difference worldwide. Could you be our next Associate Director Global Regulatory Lead, EHT (Enabling Healthcare Technologies ... connects and maintains relationships with GRAST members, including GRAS Regions and Regulatory CMC . *Applies the CSL Leadership Capabilities - Build Bridges,… more
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