- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The 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 include… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …thereby accomplishing corporate goals. **Responsibilities:** + Develop and implement US regulatory strategy for assigned project(s). Strategize and plan for ... Years in the pharmaceutical industry required. + 8 or More Years in regulatory affairs + Experience in providing regulatory strategic input into the drug… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …+ 7 or More Years in the pharmaceutical industry + 4 or More Years in regulatory affairs , NDA, sNDA, BLA filing to FDA **Travel** Ability to travel up to ... and partner with FDA; direct, coordinate and implement the preparation of all regulatory submissions and provide regulatory support across all global projects,… more
- J&J Family of Companies (Raritan, NJ)
- …step of the way. Learn more at https://www.jnj.com/innovative-medicine We are seeking a Director , Global Medical Affairs Strategy & Execution in Oncology. ... Primary Responsibilities include, but are not limited to: The Director , Global Medical Affairs Strategy & Execution collaborates with the Global Medical … more
- Novo Nordisk (Plainsboro, NJ)
- …for a living. Are you ready to make a difference? The Position The Associate Director , Regulatory Affairs - Advertising & Promotion will provide strategic ... Establish strong and positive working relationship with OPDP reviewers. Report to Senior Director , Regulatory Affairs - Advertising & Promotion. Essential… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …be responsible for bringing the issue and potential solutions to the Head of US Regulatory Affairs in conjunction with the assigned US RA strategist on the ... transparent ways of working across the Alliance within US regulatory affairs and will work closely with...for operational matters. **Responsibilities:** + Develop and implement US regulatory strategy for assigned project. Lead and… more
- AbbVie (Branchburg, NJ)
- …YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Associate Director , Regulatory Affairs US Advertising and Promotion is ... responsible for setting strategy and leading cross-functional, multidisciplinary, therapeutic teams, and executes...industry experience. Certification a plus + Experience in US Regulatory Affairs Advertising and Promotion preferred +… 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 ... you will be considered the resident expert in Global Regulatory Affairs Region NA, Advertising & Promotion...and direct reports. + In conjunction with the Sr. Director /Product Support Head, imparts senior regulatory guidance… more
- Merck (Rahway, NJ)
- …Development Execution, The primary function includes coordinating various GRACS (Global Regulatory Affairs and Clinical Safety) functional areas, to ensure ... and Inclusion principles. **Desired Experience:** + Experience with Alliance Management and/or Regulatory strategy and process for partnerships (multiple deal or… more
- Novo Nordisk (Plainsboro, NJ)
- …+ Project Management: + Cross-functional collaboration - Global Research, Global Development, Strategy Access Marketing, Medical Affairs Regulatory Safety, ... across stakeholders (Global Research, Global Development, Market Access, Marketing, Regulatory Affairs , Safety, International Operations, Regions & Affiliates,… more
- Mallinckrodt Pharmaceuticals (Bridgewater, NJ)
- Job Title Director , Clinical Development and Medical Affairs (nitric oxide) Requisition JR000014860 Director , Clinical Development and Medical Affairs ... (Open) Location Bridgewater, NJ Additional Locations Job Description Summary Job Description The Director of Clinical Development and Medical Affairs plays a key… more
- Novo Nordisk (Plainsboro, NJ)
- …key external partners + Cross-functional collaboration - Global Research, Global Development, Strategy Access Marketing, Medical Affairs Regulatory Safety, ... across stakeholders (Global Research, Global Development, Market Access, Marketing, Regulatory Affairs , Safety, International Operations, Regions & Affiliates,… more
- Bristol Myers Squibb (Madison, NJ)
- …and in their personal lives. Read more: careers.bms.com/working-with-us . The Medical Director , US Medical, Multiple Myeloma will report to the Senior Director ... the US Commercialization organization, WW Medical, Clinical Research and Development, Regulatory , Translational Development, and Market Access, and will lead the US… more
- Abbott (Princeton, NJ)
- …Affairs (GMSA), Abbott Point of Care + Contribution to global Medical & Scientific Affairs strategy in conjunction with Directors of EMEA and APAC Medical ... scientific dissemination of information + Cross-functional collaboration/interaction with Clinical Affairs , R&D, Regulatory , Quality, OEC, Legal, Global… 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 + ... Sr. Medical Director , Medical Affairs Princeton, NJ, USA...to achieving corporate objectives while maintaining the highest ethical, regulatory , and scientific standards. Performance Objectives: + Strategically work… more
- Taiho Oncology (Princeton, NJ)
- …functions at Taiho such as: Clinical Development, Commercial, HEOR, Market Access and Regulatory Affairs , Patient Advocacy, TOE, TPC and global teams to ensure ... Medical Director , Medical Affairs Princeton, NJ, USA...to achieving corporate objectives while maintaining the highest ethical, regulatory , scientific standards and meaningful differentiation for medical practice… more
- Merck (Rahway, NJ)
- **Job Description** We are seeking a Director (Principal Scientist), Global Regulatory Affairs Liaison with a visionary, growth-oriented mindset that can ... advance our pipeline and drive our strategic priorities. The Director , Principal Scientist | Regulatory Affairs...Liaison is responsible for development and implementation of worldwide regulatory strategy for their assigned projects in… more
- System One (Florham Park, NJ)
- Job Title: Director , US Regulatory Affairs Location: Florham Park, NJ (50% hybrid) Type: contract Overview: Support the Global Therapeutic Area Lead (GTAL), ... Regulatory Affairs (Senior Director ) in...Regulatory Affairs (Senior ...clinical development (as needed) + Contributions to/ finalization of regulatory strategy plans for antimicrobials in development… more
- Bristol Myers Squibb (Madison, NJ)
- …with cross-functional teams to ensure evidence generation efforts support regulatory submissions, reimbursement decisions, and market access strategy . ... . **Position Summary:** We are seeking a dynamic and visionary Worldwide Medical Affairs Disease Area Head (WW-DAH) to oversee our Oncology Worldwide GI, GU Cancers… more
- Novo Nordisk (Plainsboro, NJ)
- …+ Project Management: + Cross-functional collaboration - Global Research, Global Development, Strategy Access Marketing, Medical Affairs Regulatory Safety, ... across stakeholders (Global Research, Global Development, Market Access, Marketing, Regulatory Affairs , Safety, International Operations, Regions & Affiliates,… more