- Merck & Co. (North Wales, PA)
- …Scientist / Director responsibilities include but are not limited to:Serve as a Regulatory CMC Project Lead and provide CMC Regulatory leadership ... with risk mitigation measures.Lead the development, communication, and review of the CMC Regulatory Strategy Document for projects of increasing complexity.Lead… more
- Merck & Co. (Rahway, NJ)
- …The Executive Director , as a senior member of the Global Regulatory Affairs and Clinical Safety: Chemistry, Manufacturing and Controls Organization (GRACS ... CMC professionals and ensuring high rigor in CMC regulatory strategy as well as delivery...is pivotal in fostering alignment and global execution across Regulatory Affairs , R&D, Manufacturing, and our Commercial… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …The 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …alignment and awareness across Global Quality and GMP related functions (Supply Chain, Regulatory Affairs , CMC , Pharmaceutical Technology) who are either ... as other research areas centered around rare diseases and immune disorders.Summary The Director , Global eQMS Management QA GMP, reports to the Senior Director ,… more
- Teva Pharmaceuticals (West Chester, PA)
- Senior Director , Regulatory Affairs CMC , Innovative Medicine (Hybrid) Date: Mar 28, 2024 Location: West Chester, United States, Pennsylvania, 19380 ... difference, and new people to make a difference with. **The opportunity** The Senior Director , Regulatory Affairs CMC is responsible to manage and help… more
- Taiho Oncology (Pleasanton, CA)
- Director , Regulatory Affairs CMC Pleasanton, CA, USA Req #355 Tuesday, March 26, 2024 Looking for a chance to make a meaningful difference in the ... Join our dynamic and expanding mid-size oncology company in the role of Director , Regulatory CMC , reporting directly to Executive Director , … more
- Lilly (Indianapolis, IN)
- …to make life better for people around the world. **Senior Advisor/ Director , Global Regulatory Affairs - CMC , Small Molecules** At Eli Lilly, we create ... need them all over the world. The Senior Advisor/ Director in Global Regulatory Affairs - CMC Small Molecules will leverage CMC technical knowledge… more
- Gilead Sciences, Inc. (Foster City, CA)
- …operates in more than 35 countries worldwide, with headquarters in Foster City, California. ** Director , CMC Regulatory Affairs - Biologics** **KEY ... RESPONSIBILITIES** The Director , CMC Regulatory Affairs for Biologics is responsible for defining regulatory strategy for one or more molecules in… more
- Boehringer Ingelheim (Ridgefield, CT)
- …Ingelheim's high regard for our employees. The Associate Director , US Product CMC Regulatory Affairs is responsible for the coordination and execution ... marketing reports per US FDA regulations. The Associate Director , US Product CMC Regulatory Affairs acts as primary internal contact for all US … more
- Lilly (Indianapolis, IN)
- …for market registrations and post-approval submissions. The regulatory scientist in Global Regulatory Affairs - CMC Biotechnology will leverage CMC ... technical knowledge and regulatory science expertise to drive regulatory CMC strategies and develop submissions for marketing authorizations for the… more
- Takeda Pharmaceuticals (Boston, MA)
- …Oligonucleotides team, you will report to the Executive Director and Head, CMC Regulatory Affairs , Pharmaceuticals. **How you will contribute:** + ... regulatory team in the development and implementation of global CMC regulatory strategies during development commercialization and post approval LCM… more
- Takeda Pharmaceuticals (Boston, MA)
- … CMC team, you will report to the Executive Director and Head, CMC Regulatory Affairs - Pharmaceuticals. **How you will contribute:** + Leads the ... with Global CMC teams and leadership through networks and enable CMC regulatory team's success in meeting goals/objectives. You will also influence… more
- Merck (Rahway, NJ)
- …The Executive Director , as a senior member of the Global Regulatory Affairs and Clinical Safety: Chemistry, Manufacturing and Controls Organization (GRACS ... CMC professionals and ensuring high rigor in CMC regulatory strategy as well as delivery...is pivotal in fostering alignment and global execution across Regulatory Affairs , R&D, Manufacturing, and our Commercial… more
- Merck (North Wales, PA)
- …/ Director responsibilities include but are not limited to:** + Serve as a Regulatory CMC Project Lead and provide CMC Regulatory leadership within ... + Lead the development, communication, and review of the CMC Regulatory Strategy Document for projects of...Support new technology development. + Demonstrate an understanding of regulatory affairs and applies this understanding to… more
- Amicus Therapeutics (Marlow, OK)
- Associate Director CMC RA Location Marlow, UK...matter experts in Tech Ops, Science, Quality and Global Regulatory Affairs to ensure timely delivery of ... of openings 1 Apply Now (https://phh.tbe.taleo.net/phh04/ats/careers/v2/applyRequisition?org=AMICUS&cws=37&rid=1290) Job Brief Associate Director CMC RA Amicus Therapeutics is a… more
- ThermoFisher Scientific (Wilmington, NC)
- …depend on - now and in the future. **Discover Impactful Work:** The Senior Director , Regulatory Affairs Functional Lead, FSP, provides strategic direction, ... leadership and management to the FSP Regulatory Affairs business segment + Accountable for...years of specific experience in a regulatory affairs function and speciality area (preclinical, clinical, CMC… more
- University of Colorado (Aurora, CO)
- Regulatory Affairs Program Director - 32624 University Staff **Description** **University of Colorado Anschutz Medical Campus** **Department: Gates ... Institute** **Job Title: Regulatory Affairs Program Director ** **Position...reports) according to set timelines. + Collaborate with other regulatory experts (eg, CMC , nonclinical, clinical) to… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …on real-world evidence, and creating hope for all facing illness. The Senior Director , Commercial Regulatory Affairs , is responsible for the development ... products in US and Canada. In addition, the Senior Director , Commercial Regulatory Affairs , in...Regulatory Affairs , in collaboration with Head, Regulatory Affairs and CMC -RA, will… more
- Teva Pharmaceuticals (West Chester, PA)
- Associate Director , Regulatory Affairs - West Chester, PA Date: Mar 26, 2024 Location: West Chester, United States, 1938 Company: Teva Pharmaceuticals Job ... with. **How you'll spend your day** As the Associate Director , Regulatory Affairs you will...of the regional, clinical and Chemistry Manufacturing and Controls ( CMC ) regulatory strategies with the overall global… more
- Ascendis Pharma (Palo Alto, CA)
- The Director , Regulatory Affairs will be responsible for developing and implementing global regulatory strategies encompassing clinical, non-clinical and ... and able to have extensive/in-depth interactions with departments outside of regulatory affairs ; ensures timely preparation of Health Authority submissions… more
