- Merck & Co. (Rahway, NJ)
- …Required experience and skills: Min. 5-10 years of experience with Pharmaceutical Regulatory Affairs Operations with Labeling Process and/or Digital ... Policy Implementation, Regulatory Affairs Compliance, Regulatory Compliance, Regulatory Labeling , Regulatory Operations, Regulatory… more
- Genmab (NJ)
- …Then we would love to have you join us!The Global Regulatory Labeling , Policy and Intelligence Associate Director will primarily be responsible for leading ... and/or intelligence deliverables. This role will be within Global Regulatory Affairs (GRA) and will report to...Affairs (GRA) and will report to the Sr. Director , Labeling , Policy and Intelligence. The position… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub ... applications/supplements & variations (eg, NDA, BLA, MAA). This position authors regulatory documents where necessary with supervision. This position conducts … more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Associate Director , Global Regulatory Affairs - Global Labeling Strategy **Location** : Morristown, NJ or Cambridge, MA (Hybrid) **About ... in helping our teams accelerate progress. The Associate Director , Global Regulatory Affairs - Global Labeling Strategy is responsible for leading the… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Director , Global Regulatory Affairs - Global Labeling Strategy **Location** : Morristown, NJ or Cambridge, MA (Hybrid) **About the Job** ... critical in helping our teams accelerate progress. The Director , Global Regulatory Affairs - Global Labeling Strategy is responsible for leading the… more
- Merck (Rahway, NJ)
- …**Required experience and skills:** + Min. 5-10 years of experience with Pharmaceutical Regulatory Affairs Operations with Labeling Process and/or Digital ... Policy Implementation, Regulatory Affairs Compliance, Regulatory Compliance, Regulatory Labeling , Regulatory Operations, Regulatory… more
- Gilead Sciences, Inc. (Foster City, CA)
- …fulfil their aspirations. Join Gilead and help create possible, together. **Job Description** Regulatory Affairs Labeling is a core function within Gilead's ... organization and acts as a critical strategic partner across cross-functional teams. Regulatory Affairs Labeling creates, updates, and maintains product… more
- Takeda Pharmaceuticals (Boston, MA)
- …possible in order to bring life-changing therapies to patients worldwide. Join Takeda as Director , Global Regulatory Labeling Strategy where you will be ... EU regulatory requirements and guidelines and proactive evaluation of evolving regulatory labeling landscape. + Understanding of other relevant regional … more
- Chiesi (Cary, NC)
- …+ Promotional Material/External Communications Responsibilities: + Heads Global Rare Diseases, Regulatory Affairs Ad Promo function for the United States, ... changes to existing labeling , and submission of labeling information to regulatory authorities in the...Operating Procedures for related activities and provide training to Regulatory Affairs and other departments as appropriate.… more
- Boehringer Ingelheim (St. Joseph, MO)
- …as governance review, project team meetings, planning activities and FDA communications. Associate Director Act as Regulatory Affairs (RA) core or subteam ... **Description** Manager The Manager, Regulatory Affairs (RA) Pharma Safety &...technical input for Freedom of Information Summary and product labeling for assigned projects. + Works in project teams… 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 ... correctly apply them as appropriate in product development and labeling regulatory + Regulatory Affairs Certification by RAPS a plus The range of… more
- Lundbeck (Deerfield, IL)
- Director Regulatory Affairs Alliance and Commercialization Requisition ID: 6530 Location: Deerfield, IL, US Do you want to join a team where the mission is ... - Open to candidates anywhere in the greater United States** **SUMMARY:** The Director , US Regulatory Affairs Alliance and Commercialization, will oversee… more
- Abbott (Lake Forest, IL)
- …Opportunity** Our location in **Lake Forest, IL** currently has an opportunity for the ** Director of Regulatory Affairs .** The function of a Director ... metrics/information. The individual may plan, direct, coordinate, and control the regulatory affairs activities related to products worldwide. **WHAT YOU'LL… more
- Actalent (Bowling Green, OH)
- Regulatory Affairs Director Job Description As a Regulatory Affairs Director , you will develop, implement, and coordinate compliance with ... promoting sound product stewardship. This role requires providing technical advice concerning regulatory affairs to internal team members and customers, as well… more
- Caldera Medical (Westlake Village, CA)
- Director of Regulatory Affairs ONSITE in Westlake Village, CA Caldera Medical's Mission - To Improve the Quality of Life for Women! Message from the Hiring ... Manager: The Director of Regulatory Affairs will...inspections (FDA, Notified Body, MDSAP). * Lead post market regulatory activities including labeling , promotional review, vigilance,… more
- Abbott (Alameda, CA)
- …diversity, working mothers, female executives, and scientists. **The Opportunity** This **Associate Director Regulatory Affairs - APAC** will work on-site ... Division. As a manager, the function of an Associate Director Regulatory Affairs , APAC (Asia...approve labeling to ensure compliance. + Represent regulatory affairs in product recall and recall… more
- Actalent (Valencia, CA)
- Job Title: Director of Regulatory AffairsJob Description The Director of Regulatory Affairs leads the development and execution of global ... timelines. + Supervise, mentor, and develop a team of regulatory affairs professionals. + Assign responsibilities, manage...into design inputs and outputs. + Review and approve regulatory aspects of design documentation, labeling , and… more
- Abbott (San Diego, CA)
- …working mothers, female executives, and scientists. **The Opportunity** This position, **Associate Director Regulatory Affairs ** , works out of our ... the Director of Global NPI and US Regulatory Affairs . We're empowering smarter medical and...GMPs) + Principles and requirements of promotion, advertising and labeling International treaties and regional, national, local and territorial… 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 ... thought was possible. Ready to get started? **Main Responsibilities:** + Represents Global Regulatory Affairs (US RA AdPromo) as a member of cross-functional… more
- Bausch Health (Bridgewater, NJ)
- …creates itwhere your skills and values drive our collective progress and impact. The Director of Regulatory Affairs coordinates and oversees regulatory ... industry and regulatory experience + Knowledge of pharmaceutical brand industry regulatory affairs discipline throughout the product lifecycle + Knowledge of… more
