- 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: May 15, 2024 Location: West Chester, United States, Pennsylvania, 19380 Company: Teva… 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
- 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
- Lilly (Indianapolis, IN)
- …people who are determined to make life better for people around the world. ** Associate Director ** **; CMC , Device Development Program Manager** **Functional ... leadership role that collaborates across multiple functions to arrive at a comprehensive CMC development plan. This is a highly visible and influential role in the… 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 , Process Chemistry - CMC , located at our South San ... 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
- Teva Pharmaceuticals (West Chester, PA)
- Associate Director , Regulatory Affairs - Remote OR West Chester, PA Date: May 15, 2024 Location: West Chester, United States, Pennsylvania, 19380 Company: ... difference with. **How you'll spend your day** As the Associate Director , Regulatory Affairs you...of the regional, clinical and Chemistry Manufacturing and Controls ( CMC ) regulatory strategies with the overall global… 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 (Bridgewater, NJ)
- …the job** **Our team** The team is involved in developing and executing regulatory strategies for Tzield in life cycle development stages and post marketing to ... a later diagnosis. **Main responsibilities:** + Leads the US regulatory post-marketing activities. + As a key member of...strategy in collaboration with non-US - non-EU regions / GRA- CMC / GRA-Devices. Attends HA meetings and collaborates with… 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
- Bristol Myers Squibb (New Brunswick, NJ)
- …professionally to achieve your own career goals. **Job** **Title:** Scientific Associate Director **Location:** New Brunswick **Division:** Global Production & ... at all microbiological testing locations in the BMS network. The Scientific Associate Director will also ensure appropriate strategies for DP-related… more
- Ascendis Pharma (Palo Alto, CA)
- …of the business, from drug development to marketing. Position Summary The Associate Director of Biostatistics will provide statistical leadership, oversight, ... and activities at CROs. Additional analysis support of non-clinical / biomarker / CMC data and derive insight to contribute to Ascendis' scientific research may… 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
- Sanofi Group (Framingham, MA)
- …Culture Development department within CCD located in Framingham, MA in the role of Associate Director . We are looking for a candidate with excellent scientific, ... CMC , communication, and management skills to manage a team...covering FIH to commercial process development, process characterization, and regulatory submissions + Working knowledge of GMP manufacturing +… more
- Merck (West Point, PA)
- …Process Development, Commercialization, Operations, Technical Operations, Analytical, Quality, Regulatory - CMC , and Supply Chain. Associate Director is ... **Job Description** **Position Description:** ** Associate Director ,** **Technology Transfer** **(TT)** **Systems...+ Required to comply with our company Global and regulatory requirements and execute current Good manufacturing Practices (cGMP)… more
- AbbVie (Madison, NJ)
- …with multiple driver indications within a Therapeutic Area and support the Manager, Global Regulatory Lead (GRL), Associate Director , or Director , in ... and timely response to Health Authorities during application review. . Support CMC sections of major, complex regulatory submissions, including Investigation New… more
- J&J Family of Companies (Spring House, PA)
- Associate Director , Cell Therapy Decisional Analytics - 2406185128W **Description** Johnson & Johnson is recruiting an Associate Director , Cell Therapy ... at https://www.jnj.com/. We are looking for an energetic and highly motivated Associate Director candidate with demonstrated expertise in the development and… more
- Merck (Rahway, NJ)
- …the Research & Division organization of our company. **Position Description/Summary:** The GPAM Associate Director , Project Manager, is a core member of Early ... progress the Research & Development pipeline and realize its full potential. The Associate Director is expected to provide project management leadership and… more
- Merck (Rahway, NJ)
- …Associate Principal Scientist - Device Engineering and Early Development Lead ( Associate Director Equivalent)** _Our company's Device Development (DD) Team ... the device working group and integrating device development activities into the overall CMC working group. + **Support assets in discovery** . Identify and develop… more
- Bristol Myers Squibb (Princeton, NJ)
- …personal lives. Read more: careers.bms.com/working-with-us . **Position Summary** The Associate Director , Portfolio Management Insights, Portfolio & Strategic ... divisional management.. Expertise in R&D functions (eg, Clinical Operations, CMC , Regulatory , Project management, Commercial) preferred. Demonstrated… more
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