- Bristol Myers Squibb (Indianapolis, IN)
- …in radiopharmaceuticals . We are seeking an experienced and motivated ** Senior Director , Regulatory Affairs - CMC (Manufacturing)** . This position will ... of Regulatory Affairs and will oversee and/or manage CMC regulatory functions within the RayzeBio manufacturing facility located in Indianapolis.… more
- Lilly (Indianapolis, IN)
- …need them all over the world. The Senior Advisor/ Director in Global Regulatory Affairs - CMC Pre-approval Small Molecules will leverage CMC technical ... make life better for people around the world. Lilly is looking for regulatory CMC scientists to join us in developing and bringing life-changing new medicines to… more
- Takeda Pharmaceuticals (Boston, MA)
- …of the Global Regulatory Affairs CMC team, you will report to the Senior Director Global Regulatory Affairs CMC . **How you will contribute:** + ... bring life-changing therapies to patients worldwide. Join Takeda as an Senior Manager, Global Regulatory Affairs, CMC Small Molecules where you will oversee… more
- Lilly (Indianapolis, IN)
- …medicines to patients who need them all over the world. The Senior Advisor/ Director Post approval scientist in Global Regulatory Affairs - CMC commercial ... that make life better for people around the world. Lilly is looking for post approval regulatory CMC scientists to join us in delivering life-changing new… more
- Gilead Sciences, Inc. (Foster City, CA)
- …of experience in digital or innovation roles preferred. + Strong understanding of CMC regulatory submissions and the structure/content of Module 3. + ... **1. Strategy and Roadmap Development** + Define and continuously refine a CMC RA Digital Enablement roadmap aligned to organizational priorities and enterprise… more
- Gilead Sciences, Inc. (Foster City, CA)
- …on draft regulatory guidances, and communicates changes in regulatory CMC information to project teams and senior management. + Provides advice and ... with life-threatening illnesses worldwide. **Responsibilities** + Responsible for leading all CMC regulatory activities for assigned project(s), in line with… more
- 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. ... the job:** + Lead, develop and implement small molecule CMC regulatory strategies as well as authoring...throughout product life cycle. Escalate the critical issues to senior management timely. + Lead or contribute to development… more
- Boehringer Ingelheim (Ridgefield, CT)
- …is currently seeking an Associate Director or Senior Associate Director to join our External Alternative CMC Development (EACD) department located at ... the project(s), in support of CMC development within EACD. The Associate Director / Senior Associate Director of EACD for drug product develops… more
- AbbVie (North Chicago, IL)
- …issues is required. Ability to influence internal and external experts on CMC regulatory issues, independently. + Demonstrated excellence in writing, ... Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Pharma Product Group Associate Director will be fully accountable for providing CMC leadership and… 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
- Merck (North Wales, PA)
- …products that improve human health and business. Under GPAM, the CMC Integrated Project Management (CIPM) organization supports Development and Commercialization ... Teams (DCTs) responsible for building and executing CMC development plans. Under the guidance of the CIPM...Manager & Portfolio Lead, the core responsibility of this senior Project Manager (PM) role will be to manage… more
- Lilly (Indianapolis, IN)
- …to make life better for people around the world. **Purpose:** The purpose of the Senior Director , Global Regulatory Affairs, Global Regulatory Lead (GRL) ... development experience for 10 years + Direct experience in clinical and CMC regulatory sciences + Experience in applicable therapeutic area + Knowledge of Global… more
- Bristol Myers Squibb (Summit, NJ)
- …in their personal lives. Read more: careers.bms.com/working-with-us . **Position Summary** The Senior Director , Cell Therapy Global Product Quality Lead ( Sr. ... execute product quality strategies . **Key responsibilities :** The Senior Director , Cell Therapy Global Product Quality...queries, as needed . + R epresent Quality in CMC meetings with global regulatory agencies and… more
- Sumitomo Pharma (Topeka, KS)
- …currently seeking a dynamic, highly motivated, and experienced individual for the position of ** Director Regulatory Affairs** . The Director is part of the ... (GRA) team based in the US. He/she will primarily function as the Regional Regulatory Leader (RRL) and/or Global Regulatory Leader (GRL) for assigned projects.… more
- Lilly (Indianapolis, IN)
- …to make life better for people around the world. **Purpose:** The purpose of the Senior Director Global Regulatory Affairs, Global Regulatory Lead (GRL) ... Industry-relatedexperiencein regulatoryaffairsand/ordrugdevelopmentexperiencefor 10years + Direct experience in clinical and CMC regulatory sciences + Experience in applicable… more
- Bristol Myers Squibb (Devens, MA)
- …alongside some of the brightest minds in Biopharma. **Position Summary** The Senior Director , Head of Potency and Impurity Assay Development (PIAD) ... the next generation of scientific and organizational leaders. **Key Responsibilities** The Senior Director , Head of Potency and Impurity Assay Development… more
- Orchard Therapeutics (Boston, MA)
- …closely collaborate with the assigned US Regulatory lead, their peers in Europe, the Regulatory CMC team and the VP of Regulatory Science, to ensure a ... Location: Boston, MA Main responsibilities The Executive Director (ED) Regulatory Science will actively...technical development of gene or cell-based therapies and associated regulatory CMC activities is not requested. .… more
- Kelly Services (South San Francisco, CA)
- …external partnership management across our investigational and commercial portfolio. Reporting to the Senior Director of CMC , you'll be instrumental in ... of Drug Substance Manufacturing **Position Type:** Direct hire **Salary:** Director , $245,000-285,0000 Senior Director , $275,000...overseeing API process scale-up, regulatory strategy, and operational excellence required for clinical and… more
- System One (Alameda, CA)
- …and build comprehensive DMPK packages to enable successful drug registration. The senior director is responsible for providing strategic and technical subject ... and oversight for the DMPK support of several programs in portfolio. The Senior Director contributes to growth of the Clinical Pharmacology and Pharmacometrics… more
- Fresenius Medical Center (Waltham, MA)
- …pharmaceutical portfolio, including IND/CTAs, NDAs, NDSs, MAAs, etc..and other key regulatory submissions. + Collaborate with senior leadership in ... considerations into all stages of product development, including preclinical, clinical/medical, CMC , and post-market phases. + Monitor regulatory trends,… more
Related Job Searches:
CMC,
CMC Director,
CMC Regulatory,
Director,
Director Regulatory CMC,
Director Senior Regulatory,
Regulatory,
Regulatory Director,
Senior,
Senior Director