- Genmab (Remote, OR)
- …drug development and regulatory requirements. The work done by the Associate Director , Medical Writing is complex and strategic and requires advanced ... other clinical documentation to support the conduct of the clinical trials and regulatory submissions/filings. The Associate Director , Medical Writing may… more
- Bristol Myers Squibb (Princeton, NJ)
- …both at work and in their personal lives. Read more: careers.bms.com/working-with-us . The CMC Regulatory Associate Director , Biologics is responsible ... practical aspects of global change management. **Position Summary / Objective** The CMC Regulatory Associate Director , Biologics is responsible for… more
- Teva Pharmaceuticals (West Chester, PA)
- …with 4 direct reports (Dir, Sr Manager, Manager & Associate III). The Sr Director , Regulatory Affairs CMC is responsible for identifying and evaluating ... Senior Director Regulatory Affairs CMC (Biologic Products) Date: Jun 13, 2024 Location: West Chester, United States, Pennsylvania, 19380 Company: Teva… more
- Gilead Sciences, Inc. (Foster City, CA)
- …aspirations. Join Gilead and help create possible, together. **Job Description** The Associate Director , Analytical Regulatory Science, collaborates with ... be accountable for the interpretation and implementation of new and existing CMC regulatory guidelines and regulations to ensure approvability globally.… more
- Regeneron Pharmaceuticals (Troy, NY)
- The Director of CMC Industry and Regulatory Intelligence is responsible for enabling chemistry manufacturing and controls ( CMC ) quality and compliance ... all CMC operations across Regeneron. As a Director of CMC Industry and Regulatory...health, environment or politics or related degree and: + Associate Director : 15+ years of related experience… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. **Summary** The Associate Director , RACMC, is responsible for the regulatory CMC (Chemistry, ... serve as G-RACMC lead or regional submission lead. Provide regulatory guidance and strategy to CMC sub-team and G-RA teams along with other functional teams… more
- AbbVie (North Chicago, IL)
- … CMC activities with respect to science, technology, quality, regulatory /compliance requirements, budget and resources. *Must possess good scientific writing ... matrix management approach; Key member of Asset Strategy Team (AST) and ensures CMC strategy is closely aligned with the clinical and regulatory development… more
- AbbVie (North Chicago, IL)
- …issues is required. Ability to influence internal and external experts on CMC regulatory issues, independently. + Demonstrated excellence in writing, ... or functions or outputs of this position. Full time/dedicated responsibility for CMC leadership and project management for commercial and pipeline small molecule… more
- Sanofi Group (Framingham, MA)
- …to process development activities. + Broad knowledge of (bio)pharmaceutical development and CMC activities in a regulatory context, including good understanding ... discovery and development to find answers for patients and their families. The CMC -Biologics Statistics team is seeking an expert data scientist / Statistician to… 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
- Frontier Medicines (South San Francisco, CA)
- Join Frontier Medicines on an exciting journey as our newest Principal Scientist/ Associate Director , CMC Development located at our South San Francisco ... of our team, reporting directly to the Head of CMC , you'll play an integral role in advancing our...thorough understanding of ICH guidelines, GLP/GMP manufacturing, and related regulatory requirements is required + Ability to travel domestically… more
- WuXi AppTec (Philadelphia, PA)
- …Overall responsibility for the analytical strategy, execution, tracking, and preparation of regulatory filing documents for the analytical part of cell and gene ... projects, ensuring timely and high-quality delivery **Responsibilities** * Provide analytical CMC -related support for new working order signing at BD, participate in… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Associate Director , RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, Manufacturing, and Controls) activities of the portfolio ... be responsible for working on cross-functional teams, developing and executing post-approval Regulatory CMC strategies, reviewing CMC information and data,… more
- Sanofi Group (Cambridge, MA)
- **Job title: Device Regulatory Lead ( Associate Director )**...of products. The team is part of the Global Regulatory Affairs, Regulatory CMC and ... PA or Cambridge, MA **About the job** The Global Regulatory Affairs Device team is a globally diverse team...territories that need "new" thinking and approaches from a regulatory perspective. You will be expected to proactively initiate… more
- Teva Pharmaceuticals (West Chester, PA)
- Associate Director , Drug Product Development Date: Jun 22, 2024 Location: West Chester, United States, Pennsylvania, 19380 Company: Teva Pharmaceuticals Job Id: ... process, and process tech transfer to GMP manufacturing sites. Associate Director is a key leadership role...to progress biologic products. + Experience authoring and reviewing regulatory submissions related to CMC activities. +… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …New Modality) team. - Support the compilation and technical review of relevant CMC sections of regulatory submissions (INDs/IMPDs, NDAs, BLAs, etc.), responses ... (mAb, Drug Substance, Drug Product, or New Modality) manufacturing, evaluates CMC risks for appropriate escalation, recommends transition milestones and ensures a… more
- Takeda Pharmaceuticals (Boston, MA)
- …Be well versed in all stages of pharmaceutical development and understands the global regulatory trends for CMC activities, to ensure robust and high-quality ... to the best of my knowledge. **Job Description** **OBJECTIVES** **:** + Global CMC program oversight of Pharmaceutical Sciences (PS) with management and oversight of… more
- Frontier Medicines (South San Francisco, CA)
- Frontier Medicines is seeking a highly motivated individual for a newly created Associate Director role in Process Chemistry in Frontier's South San Francisco ... scale-up challenges + In collaboration with the Development Project Lead and/or CMC Head, define timelines, production scale, and budget to support all development… more
- Takeda Pharmaceuticals (Lexington, MA)
- …is true to the best of my knowledge. **Job Description** The Associate Director , Clinical Research provides clinical project management and leadership ... in leading cross-functional clinical programs within Medical Affairs, Clinical Research, Regulatory , CMC or other drug development related function. +… more
- Takeda Pharmaceuticals (Boston, MA)
- …the best of my knowledge. **Job Description** **_Objective / Purpose:_** As an Associate Director in Analytical Development, it is expected that the individual ... regulatory submissions. Knowledgeable in European, Japanese, Chinese and US CMC regulatory requirements for Biologics + Represents AD and provide guidance to… more
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