- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Liaisons to ensure successful implementation of CDx and data collection Supports Regulatory affairs in providing content and providing review of documents ... to ensure successful implementation of the CDx and associated data collection. Oversees clinical trial sample testing activities and data capture to support CDx … more
- Genmab (NJ)
- …with key stakeholders within Global Development Operations (GDO), Medical Affairs , Medical, and/or CROs, to enable expedited, predictive delivery for ... competitive landscape) that represent operational risks for the execution of clinical trials within the given indication/program.Key contributor to the study's… more
- Abbott (Alameda, CA)
- …work for diversity, working mothers, female executives, and scientists. **The Opportunity** This ** Associate Director Regulatory Affairs - APAC** will work ... Diabetes Division. As a manager, the function of an Associate Director Regulatory Affairs , APAC...Provide guidance for resource and development planning + Approve regulatory filing strategies based upon proposed preclinical, clinical… more
- Takeda Pharmaceuticals (Boston, MA)
- …is possible in order to bring life-changing therapies to patients worldwide. The Associate Director, Global Regulatory Affairs Advertising and Promotion (GRA ... pertaining to prescription medicine promotion. **How you will contribute:** + As our Associate Director, Global Regulatory Affairs Advertising and Promotion… more
- Abbott (San Diego, CA)
- …diversity, working mothers, female executives, and scientists. **The Opportunity** This position, ** Associate Director Regulatory Affairs ** , works out of ... reporting to the Director of Global NPI and US Regulatory Affairs . We're empowering smarter medical and...and mentor regulatory professionals. **Premarket:** + Approve regulatory filing strategies based on proposed preclinical, clinical… more
- Bausch Health (Bridgewater, NJ)
- …it-where your skills and values drive our collective progress and impact. The Associate Director, Regulatory Affairs handles regulatory development ... assigned pharmaceutical products. + Coordinate/Liaise with BHC country-specific pharmaceutical Regulatory Affairs personnel for international submissions and… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- The Associate Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products. Responsibility will mainly ... focus on Clinical Regulatory filings and provide regulatory leadership on the project teams in this area. We are a hands-on culture so responsibilities will… 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 the CMC sub ... technical teams in preparation of submission documents to include clinical trial applications/amendments (eg, IND, IMPD, IB) and marketing applications/supplements… more
- University of Colorado (Aurora, CO)
- …- Senior/Level 3) - 36956 University Staff As an important member of the Cancer Clinical Trials Office (CCTO) Regulatory Affairs team, this position works ... ** Regulatory Affairs Coordinator (Open Rank: Entry/Level... Clinical Research Professional + CCRA - Certified Clinical Research Associate **Knowledge, Skills and Abilities:**… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …pharmaceutical industry experience required + 4 or More Years of direct regulatory affairs experience, including US labeling experience required + Experience ... This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product… more
