- Gilead Sciences, Inc. (Parsippany, NJ)
- …to fulfil their aspirations. Join Gilead and help create possible, together. **Job Description** Regulatory Affairs Global Labeling is a core function within ... Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner across cross-functional teams. Regulatory Affairs Global … more
- Bausch Health (Bridgewater, NJ)
- …writing CCDS and USPI documents for new products. + Solid understanding of pharmaceutical regulatory affairs , global labeling regulatory requirements and ... skills and values drive our collective progress and impact. The Global Labeling Director provides regulatory expertise and guidance for labeling strategy,… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Global Regulatory Affairs Device Head, Specialty Care Device and Combination Products (Sr. Director ) **Location** : Cambridge, MA or ... skills could be critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device Head, Specialty Care Device and Combination… more
- Bayer (NJ)
- …colleagues and the FDA; + Acts as a critical collaborative partner with the Global Regulatory Affairs organization to ensure FDA/US input into product ... to make a real difference, there's only one choice.** ** Director US Regulatory Affairs Liaison**...USPI) and packaging in close collaboration with the GRS, Global Regulatory Affairs Labeling, US… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …and real-world evidence, US and global commercial teams, market access, and regulatory affairs , to ensure integrated global strategies and cohesive ... experienced Medical Director of CNS Early Assets, Global Medical Affairs , responsible for certain assets...or early development (phase 1) assets either within Medical Affairs , Regulatory Affairs , or Clinical… more
- J&J Family of Companies (Raritan, NJ)
- …of America **Job Description:** Johnson and Johnson is currently seeking a **Medical Director , Global Medical Affairs , Biosurgery located** in **Raritan, ... with business partners including but not limited to R&D, Clinical Research, Regulatory Affairs , Communications, Legal, Quality & Compliance, Preclinical, Health… more
- Merck (Rahway, NJ)
- …position will be part of the Device Quality & Regulatory Team within Global Regulatory Affairs and Clinical Safety (GRACS). The primary responsibility ... system aspects are integrated + Stay abreast of evolving global regulatory landscapes for medical device and...+ Audit vendors/partners of SaMD/IVD/Companion Diagnostics **Reports to** - Director Regulatory Compliance, Device Quality 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 ... Join our global diversified pharmaceutical company enriching lives through our...assigned pharmaceutical products. + Coordinate/Liaise with BHC country-specific pharmaceutical Regulatory Affairs personnel for international submissions and… more
- Sanofi Group (Morristown, NJ)
- **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
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- **Job Description Summary** As Regulatory Affairs Associate Director , you will be responsible for leading RA team members involved in device project ... makers of possible** BD is one of the largest global medical technology companies in the world. Advancing the...preferred; medical training preferred. + Minimum 8 years of regulatory affairs experience within the pharmaceutical or… 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 ... Join our global diversified pharmaceutical company enriching lives through our...regulatory experience + Knowledge of pharmaceutical brand industry regulatory affairs discipline throughout the product lifecycle… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …product development, meet regulatory requirements, and support appropriate use. The Director of Medical Affairs needs to have strong strategic and ... of possible** ! BD is one of the largest global medical technology companies in the world. _Advancing the...directly to the business unit Vice President of Medical Affairs , the Director of Medical Affairs… more
- Amneal Pharmaceuticals (Piscataway, NJ)
- …to department and company goals and objectives. Essential Functions: + Develop and Execute Global Regulatory Strategies: Formulate and lead global CMC and ... including preparing briefing books, planning rehearsals, and risk mitigation. Represent Global Regulatory on cross-functional teams to address regulatory… more
- Taiho Oncology (Princeton, NJ)
- …such as: Clinical Development, Commercial, Evidence and Value Development, Market Access and Regulatory Affairs to ensure, as needed, alignment and inputs + ... plans for successful commercialization of assigned indications. Position Summary: The Sr. Medical Director , Medical Affairs (SMD, MA) needs to be an expert in… more
- Grifols Shared Services North America, Inc (Freehold, NJ)
- …plans in Immunology- and Infectious Disease-related therapeutic areas. Develop and lead Medical Affairs initiatives and strategies aligned with the global and US ... Innovation Office and commercial functions. 2. Support development of global and US medical affairs plans in...**Pay Scale:** The estimated pay scale for the Medical Affairs Scientific Director 2 role based in… more
- System One (Florham Park, NJ)
- Job Title: AD or Director , Regulatory Affairs Strategy Location: Florham Park, NJ (50% hybrid) Type: 12-month contract Must haves: + Must be local for hybrid ... development, not just life cycle management. Overview Support the Regulatory Affairs (Executive Director ) in...to provide background insights. + Assist in Coordinating with Global Regulatory Counterparts to Align Regional Strategies… more
- Bristol Myers Squibb (Princeton, NJ)
- …in their personal lives. Read more: careers.bms.com/working-with-us . The Associate Director , WW Medical Cell Therapy Autoimmune, LCM/Pan-Indication, will report to ... will also support the execution of BMS sponsored Medical Affairs trials, and assist in the evaluation and support...and contributes to the ACTion network deliverables + Supports global medical strategy and tactics across the autoimmune portfolio… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- … Regulatory Affairs and may serve as Regional Lead or Global Regulatory Lead on cross-functional/cross-regional Regulatory Submission Teams. Provides ... assigned products or projects. You may act as the Global Regulatory Lead for early-stage or other...current global and regional trends in biopharmaceutical regulatory affairs . Proven effectiveness applying this knowledge… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- … Regulatory Affairs and may serve as Regional Lead or Global Regulatory Lead on cross-functional/cross-regional Regulatory Submission Teams. Provides ... assigned products or projects. You may act as the Global Regulatory Lead for early-stage or other...or special projects that continuously improve or otherwise advance Regulatory Affairs capabilities. You will also help… more
- Sanofi Group (Morristown, NJ)
- …the IEGP. The Medical Director will collaborate with internal experts from Global and Local Medical, Clinical Development, and Regulatory teams to develop, ... **Job title** : Global Medical Director , Evidence Generation -...with glocal cross-functional teams including Medical TA, Clinical Development, Regulatory Affairs , HEVA, Market Access, and Commercial… more