- Regeneron Pharmaceuticals (Tarrytown, NY)
- …a timely manner + Participate in global RA meetings, provide regulatory interpretation, position, and strategies to support CMC /CP prduct development ... typical day might include the following:** + Responsible for CMC /CP product development activities to lead the regulatory...have:** + Need to have good understanding of current CMC /CP RA worldwide regulations. + Proven track… more
- 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)
- … information to project teams. + Works independently with directional support from a Senior Regulatory Affairs professional. Requirements + BS/BA Degree in a ... of the business, from drug development to marketing. The Manager , Regulatory Affairs will be.... Key Responsibilities + Responsible for strategic and operational regulatory input and support for cross functional ( CMC… 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: Aug 14, 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
- Bill and Melinda Gates Foundation (Seattle, WA)
- …Integrated Development (IDev) team comprises 4 domains: Quantitative Sciences, Regulatory Affairs , Decision, Analyze, Communicate (DAC), Chemistry, Manufacturing ... and Controls ( CMC ). IDev plays a meaningful role in advancing the...PM PDT) Position Summary As the Seni or Program Manager , you are responsible for supporting the strategic and… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …have:** + Minimum Bachelor's Degree. Advanced life science degree or certification in Regulatory Affairs Sciences preferred. + Minimum of 5 years' experience in ... Regeneron is seeking a Manager to join the Regulatory Intelligence...or more of these additional areas is a plus: CMC /Mfg., Clinical development and trial execution, Regulatory ,… more
- BD (Becton, Dickinson and Company) (Warwick, RI)
- …Marketing, Operations, and Finance. The Senior Quality Engineer interacts with Regulatory Affairs regarding new regulations and standards as they apply to ... **Job Description Summary** The Senior Quality Engineer is responsible for supporting Design... Quality Engineer works closely with shared functions (eg Regulatory Affairs , Designated Complaint Handling Unit (DCHU),… more