- BD (Becton, Dickinson and Company) (San Diego, CA)
- …and Friday remotely on a weekly basis. **Summary of Job Responsibilities** The Associate Director of Regulatory Affairs will provide regulatory support ... regulatory strategies for new product submissions, project management for regulatory affairs submissions, handling existing product registrations including… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Director , US Regulatory Affairs - Advertising and Promotion **Location:** Cambridge, MA or Morristown, NJ **About the job** Are you ready to ... and direct reports. + In conjunction with the Sr. Director /Product Support Head, imparts senior regulatory guidance...8+ years of experience within pharmaceutical or medical device Regulatory Affairs + Successful track record of… more
- AbbVie (Irvine, CA)
- …YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Associate Director of Regulatory Affairs - Soft Tissue Fillers ... interactions with R&D, Quality, Medical Safety and International Regulatory Affairs colleagues. + Provides regulatory...Bachelor's degree or equivalent. Relevant advanced degree in a scientific discipline is highly desirable. + At least 10… more
- Takeda Pharmaceuticals (Boston, MA)
- …of technical success for the solutions. + Effectively represent the Global Regulatory Affairs (GRA) function in senior level interactions at internally ... NDA, 510K, CE Mark submissions and their amendments/supplements). + Understanding of scientific principles and regulatory Device requirements relevant to global… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Advertising and Promotion (RA Ad/Promo) is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner across ... critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as...Experience working with external contractors supporting the work of regulatory affairs is a plus. + Experience… more
- Bausch Health (Bridgewater, NJ)
- …CCDS and USPI documents for new products. + Solid understanding of pharmaceutical regulatory affairs , global labeling regulatory requirements and industry ... skills and values drive our collective progress and impact. The Global Labeling Director provides regulatory expertise and guidance for labeling strategy, to… more
- AbbVie (Mettawa, IL)
- …onsite 3 days per week in Mettawa, IL. The Medical Director , Medical Affairs serves as a strategic medical and scientific expert within the organization, ... ) as they relate to on-going medical affairs projects. Serves as the scientific team interface for key regulatory discussions. . Serve as a therapeutic area… more
- J&J Family of Companies (Palm Beach Gardens, FL)
- …+ Work with cross-functional partners, including but not limited to R&D, Clinical Affairs , Regulatory Affairs , Health Economics & Market Access (HEMA) ... **Job Function:** Medical Affairs Group **Job Sub** **Function:** Medical Affairs - MD **Job Category:** Scientific /Technology **All Job Posting Locations:**… 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 ... science and technology. With more than 100 years of scientific expertise and a presence in more than 20...& variations (eg, NDA, BLA, MAA). This position authors regulatory documents where necessary with supervision. This position conducts… more
- Mallinckrodt Pharmaceuticals (Bridgewater, NJ)
- …statistics, regulatory , etc.) as they relate to on-going medical affairs projects. + Provides scientific /medical education to investigators, clinical ... Job Title Director , Clinical Development and Medical Affairs ...with other internal stakeholders including clinical operations, statistics and regulatory . + Provides scientific and technical support… more