- Gilead Sciences, Inc. (Foster City, CA)
- …worldwide, with headquarters in Foster City, California **About the role:** The CMC Regulatory Affairs Sr. Manager at Gilead is responsible for providing ... contributes to global process improvements, which have a significant impact for the Regulatory Affairs CMC Department or development matrix teams + Coach and… more
- Astellas Pharma (Westborough, MA)
- ** Regulatory Manager , Regulatory Affairs - CMC (Gene Therapy)** Do you want to be part of an inclusive team that works to develop innovative ... with functional peer groups internally and externally, occasionally with senior management. + Advises local teams on regulatory...for eligible positions + Referral bonus program \#LI-TR1 Category Regulatory Affairs CMC Astellas is… more
- BeiGene (San Mateo, CA)
- **General Description:** + The Manager , Regulatory Affairs CMC , is responsible for developing and implementing global regulatory CMC strategies ... organization. **Significant Contacts** + Interacts with BeiGene employees and senior management. + Interacts with external business partners and...with minimum 5+ years of experience in a global CMC regulatory affairs position (with… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …including working with contract manufacturing organizations CMO.** This position serves as the Regulatory Affairs ( RA ) CMC project representative to ... manager . + ** Regulatory Knowledge:** Demonstrates expert knowledge of US/EU regulatory guidances. Serves as RA CMC representative supporting company… more
- Ascendis Pharma (Palo Alto, CA)
- …and perspectives to all aspects of the business, from drug development to marketing. The Senior Manager , Regulatory Affairs will be responsible for ... information to project teams. + Works independently with directional support from a Senior Regulatory Affairs professional. Requirements + BS/BA Degree in a… more
- West Pharmaceutical Services (Exton, PA)
- …and Post-Approval) and ensure timely execution of project objectives in line with regulatory affairs ( RA ) team's priorities. + Manage the preparation, ... Date: Sep 12, 2024 Location: Exton, Pennsylvania, US Department: Regulatory Affairs Description: **_This position is hybrid...IEC 62304, ISO 11608), 21 CFR Part 820 and CMC regulatory requirements. + Experience in medical… more