- Lilly (Indianapolis, IN)
- …people who are determined to make life better for people around the world. ** Associate Director ** **; CMC , Device Development Program Manager** **Functional ... better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees...collaborates across multiple functions to arrive at a comprehensive CMC development plan. This is a highly visible and… more
- AbbVie (North Chicago, IL)
- …through regular communications and periodic reviews throughout development and in support of global filings and approvals. + Represents all CMC areas on the ... of global filings. + Responsible for the global filings of high quality CMC dossiers,...for the global filings of high quality CMC dossiers, approvals and commercialization of products. Qualifications *Bachelor's… 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 ... people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...areas centered around rare diseases and immune disorders. **Summary** CMC Lead is responsible for supporting the overall … more
- AbbVie (North Chicago, IL)
- …quality and analytics is required. + Knowledge and experience with FDA and global regulatory requirements for CMC issues is required. Ability to influence ... or functions or outputs of this position. Full time/dedicated responsibility for CMC leadership and project management for commercial and pipeline small molecule… more
- Teva Pharmaceuticals (West Chester, PA)
- …a difference, and new people to make a difference with. **The opportunity** The Sr. Director , Global Regulatory Affairs CMC is responsible to oversee and ... Manager, Manager & Associate III). The Sr Director , Regulatory Affairs CMC is responsible for...for Teva products, and for ensuring the quality of CMC response to global health authorities. The… more
- Regeneron Pharmaceuticals (Troy, NY)
- …and made available throughout IOPS + Monitors and assesses all sources of global CMC intelligence information, including industry trends, for relevance and ... The 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)
- …research areas centered around rare diseases and immune disorders. **Summary** The Associate Director , RACMC Portfolio Products, will be responsible for ... people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...regulatory CMC (Chemistry, Manufacturing, and Controls) activities of the portfolio… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... (mAb, Drug Substance, Drug Product, or New Modality) manufacturing, evaluates CMC risks for appropriate escalation, recommends transition milestones and ensures a… 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: Teva ... difference with. **How you'll spend your day** As the Associate Director , Regulatory Affairs you will be...of the regional, clinical and Chemistry Manufacturing and Controls ( CMC ) regulatory strategies with the overall global … more
- Bristol Myers Squibb (New Brunswick, NJ)
- …your own career goals. **Job** **Title:** Scientific Associate Director **Location:** New Brunswick **Division:** Global Production & Supply/Pharmaceutical ... at all microbiological testing locations in the BMS network. The Scientific Associate Director will also ensure appropriate strategies for DP-related… 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, ... **Position Summary** The global Cell Culture Development (CCD) organization within Sanofi operates...CMC , communication, and management skills to manage a team of… 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 ... cross-functional clinical programs within Medical Affairs, Clinical Research, Regulatory, CMC or other drug development related function. + Experience managing… more
- Sanofi Group (Bridgewater, NJ)
- …support the Diabetes Franchise business, driving the growth of the General Medicines Global Business Unit. In our team, you will manage the US post-marketing ... post-marketing activities. + As a key member of the Global Regulatory Team (GRT), and strategic partner to the...strategy in collaboration with non-US - non-EU regions / GRA- CMC / GRA-Devices. Attends HA meetings and collaborates with… more
- Merck (West Point, PA)
- …Health, Process Development, Commercialization, Operations, Technical Operations, Analytical, Quality, Regulatory- CMC , and Supply Chain. Associate Director ... **Job Description** **Position Description:** ** Associate Director ,** **Technology Transfer** **(TT)** **Systems Group Leader** As part of our Manufacturing… 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 ... Description** The drug development Project Manager is part of Global Project and Alliance Management (GPAM) which sits in...& Development pipeline and realize its full potential. The Associate Director is expected to provide project… more
- CSL Behring (King Of Prussia, PA)
- …market biotherapies used to treat serious and often rare conditions. Could you be our Associate Director , Safety Systems Program Lead? The job is located in the ... CSL Behring is a global biotechnology leader, guided by a promise to...is a hybrid position. You will report to the Director , Safety Systems Program Lead. Responsibilities: + You will… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …on real-world evidence, and creating hope for all facing illness. The Associate Director , Business Development will seek out potential business opportunities ... pharmaceutical company that has tirelessly pursued medical breakthroughs with global reach. MTPC has discovered and produced several first-in-class medicines… more
- Bristol Myers Squibb (Trenton, NJ)
- …personal lives. Read more: careers.bms.com/working-with-us . **Position Summary** The Associate Director , Portfolio Management Insights, Portfolio & Strategic ... (P&SO), drives portfolio management insights development and delivery to the Global Program Teams (GPTs), Therapeutics Areas (TAs) leaders, Hematology Oncology Cell… more
- Sanofi Group (Swiftwater, PA)
- …products within the Sanofi portfolio of products. The team is part of the Global Regulatory Affairs, Regulatory CMC and Device Department within Global ... **Our Team:** The Global Regulatory Affairs Device team is a globally...perspective as a member of project specific cross functional global regulatory team (GRT) and is accountable to develop… more
- AbbVie (Madison, NJ)
- …with multiple driver indications within a Therapeutic Area and support the Manager, Global Regulatory Lead (GRL), Associate Director , or Director ... on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description Senior Manager, Global Regulatory Strategy, US & Canada, AbbVie Inc., Madison / Florham Park… more
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