- 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
- J&J Family of Companies (Columbus, OH)
- Associate Director , Regulatory Affairs - 2406166277W **Description** Janssen Research & Development, LLC, a member of Johnson & Johnson's Family of ... Companies, is recruiting for an Associate Director , Regulatory Affairs . This position...alignment with NA regional teams, Chemistry, Manufacturing, and Controls ( CMC ), commercial strategies, and the Target Product Profile. +… more
- Boehringer Ingelheim (Ridgefield, CT)
- **Description** The Executive Director of the US Regulatory Affairs CREA Product Group serves on the US Regulatory Leadership Team responsible for ... 8-10 years' experience in the pharmaceutical industry that includes experience in Regulatory Affairs . + Demonstrated strong leadership and communications skills.… more
- Organon & Co. (Jersey City, NJ)
- **Job Description** **The Position** Reporting to the Director in Regulatory Chemistry, Manufacturing & Controls ( CMC ), the Senior Scientist is responsible ... for the preparation and review of information required for development of regulatory CMC dossiers for products including original registrations, life-cycle… more
- Ascendis Pharma (Palo Alto, CA)
- …position will be based in Palo Alto, CA and reports directly to the Senior Director , Regulatory Affairs . Key Responsibilities + Responsible for strategic and ... the business, from drug development to marketing. The Manager, Regulatory Affairs will be responsible for supporting...operational regulatory input and support for cross functional ( CMC… more
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