- 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...is a plus. + Demonstrated leadership as a people manager . + Experience in authoring complex technical documents, CTD… more
- Gilead Sciences, Inc. (Foster City, CA)
- …**Job Description** This exciting role of Regulatory Affairs Associate II, CMC sits in Gilead's CMC Regulatory Affairs - Small Molecule Group. ... plans. Shadows leads while they develop and execute robust CMC regulatory strategies. + Under the guidance...manager support. + Invests in acquiring knowledge about CMC regulatory intelligence including guidelines and … more
- Bausch Health (Bridgewater, NJ)
- …itwhere your skills and values drive our collective progress and impact. The Associate Director, Regulatory Affairs handles regulatory development and ... + Coordinate with Submissions Manager to ensure timely and accurate submissions to Regulatory Authorities + Act as a regulatory contact with Regulatory … more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …duties as required. **Additional Responsibilities, Knowledge, Skills and Abilities:** + Global Regulatory CMC Experience is preferred. + Ability to work ... to act as a team member in the product manager area of Regulatory Affairs (Biopharma) supporting...team. **Additional Responsibilities, Knowledge, Skills and Abilities:** + Global Regulatory CMC Experience is preferred. + Ability… more
- BeOne Medicines (Emeryville, CA)
- **_General Description:_** Sr. Manager / Associate Director, Supply Chain CMO Management & PM will own and enable the communication, coordinate tasks between the ... production & continuity of supply + Partner with internal stakeholders such as CMC , Regulatory , Quality to ensure on time commercial launch & new market launch… more
- Takeda Pharmaceuticals (Lexington, MA)
- …in leading cross-functional clinical programs within Medical Affairs, Clinical Research, Regulatory , CMC or other drug development related function. Clinical ... with significant experience within related functions (eg, Medical Affairs, Clinical Operations, Regulatory , CMC , Marketing). + Minimum of 5 years' experience as… more
- Gilead Sciences, Inc. (Foster City, CA)
- …documentation practices. . Author technical documents such as protocols, reports, regulatory dossier, etc. and prepare data-focused presentations for internal and ... in project meetings. . Analyze data and draft conclusions before discussing with manager or supervisor. . Support or represent function and work collaboratively on… more
- Regeneron Pharmaceuticals (Armonk, NY)
- …managers, medical monitors, as well as staff from quality, clinical compliance, regulatory , formulations, and IOPS ( CMC , external manufacturing, stability). **A ... The Manager , Clinical Drug Supply & Logistics is responsible...within budget and with good quality, in compliance with Regulatory Authorities' regulations / guidelines and Regeneron SOPs /… more
- CVS Health (Atlanta, GA)
- … within an established timeframe. + **Quality Issue Escalation:** inform the assigned care manager and/or associate manager of any identified quality of care ... coordinating care for our members through close collaboration with the Care Manager , Social Worker, and other interdisciplinary team members. This role involves… more