- Stryker (San Jose, CA)
- The **Senior Director , Regulatory Affairs** is a key strategist, responsible for developing regulatory strategy for the **Endoscopy business unit** and ... with business unit leadership, Marketing, R&D, Clinical and Quality teams, the Senior Director and team will develop and advise on product positioning, product entry… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Associate Director , Global Regulatory Affairs Advertising and Promotion **Location** : Cambridge, MA Morristown, NJ **About the Job** Are you ... of medicine? The race is on to speed up drug discovery and development to find answers for patients...accelerate progress. This individual will be responsible for providing regulatory review and approval of US promotional and other… more
- Boehringer Ingelheim (Ridgefield, CT)
- …Specialty Care/ Rare Disease pharmaceutical products. + Experience in FDA prescription drug regulatory matters including experience in the federal Anti-Kickback ... providing reimbursement, education and other support to patients. The Director & Sr. Counsel provides a broad range of...of pharmaceutical law, one of which must be FDA Regulatory (eg, patient support programs, market access, patient assistance… more
- Kemin Industries (Des Moines, IA)
- Overview Kemin Health is hiring an Associate Director of Regulatory /Scientific Affairs and Quality! In this role, you will be responsible for leading the ... business units' regulatory affairs (RA) and quality assurance (QA) teams by...accommodation will be considered. A post-offer background check and drug screen is required. Additional pre-employment requirements may be… more
- Gilead Sciences, Inc. (Foster City, CA)
- …and serious respiratory and cardiovascular conditions. **KEY RESPONSIBILITIES** The Associate Director , CMC Regulatory Affairs for Biologics is responsible for ... unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of...will ensure "right first time" global approvals of CMC regulatory (Biologics) submissions, and "right to operate" by maintaining… 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 shape ... of medicine? The race is on to speed up drug discovery and development to find answers for patients...and direct reports. + In conjunction with the Sr. Director /Product Support Head, imparts senior regulatory guidance… more
- Bristol Myers Squibb (Princeton, NJ)
- …lives. Read more: careers.bms.com/working-with-us . **Description:** The role of Associate Director of US Commercial Regulatory Affairs requires the ability ... to apply complex scientific and expert regulatory advice and risk assessment for the development of...strategic advice for the development of Office Of Prescription Drug Promotion advisory submissions and sub part e submissions… more
- Gilead Sciences, Inc. (Foster City, CA)
- …BA/BS with 10+ years' relevant experience. + 4+ years' experience in prescription drug labeling. + Significant regulatory experience in the biopharma industry is ... their aspirations. Join Gilead and help create possible, together. **Job Description** Regulatory Affairs Labeling is a core function within Gilead's Global … more
- Takeda Pharmaceuticals (Boston, MA)
- … experience in the pharmaceutical/biotech industry. + Experience in global drug development regulations, regulatory submissions, lifecycle management, compliance ... immunologic, hematologic, and other complex diseases. The Head of Global Regulatory Affairs Operations, Compliance & Process Excellence is accountable for overseeing… more
- Chiesi (Boston, MA)
- …and rewarding work. Who we are looking for Purpose Responsible for the regulatory review and submission of advertising and promotional materials for all Chiesi ... and changes to existing labeling, and submission of labeling information to regulatory authorities in the United States and Canada. Main Responsibilities +… more