- 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
- Gilead Sciences, Inc. (Parsippany, NJ)
- …regardless of where they live or their economic status. **POSITION OVERVIEW:** As a Director , Early Oncology Global Regulatory Affairs , you will develop and ... lead, manage and oversee simultaneously. You will define the regulatory strategy , plans and objectives for assigned...Strategy Teams. Provides strategic advice and guidance to Regulatory Affairs and cross-functional leaders and teams.… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …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...Proven track record in effectively setting and directing the regulatory labeling or related strategy to successful… more
- Bausch Health (Bridgewater, NJ)
- …it-where your skills and values drive our collective progress and impact. The Associate Director , Regulatory Affairs handles regulatory development and ... approved products (NDA; ANDA; BLA; OTC; Devices; Cosmetic; Nutritional). Manages relevant regulatory strategy components and interactions with Regulatory … 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
- Bausch Health (Bridgewater, NJ)
- …your skills and values drive our collective progress and impact. Job Scope: The Director of Regulatory Affairs coordinates and oversees regulatory ... to provide regulatory guidance for pharmaceutical products. Manages relevant regulatory strategy components and interactions with Regulatory Authorities… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …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 ... regulatory agencies. You will manage the commercial regulatory strategy and execution of such for...Experience working with external contractors supporting the work of regulatory affairs is a plus. + Experience… more
- Bausch Health (Bridgewater, NJ)
- …our collective progress and impact. The Global Labeling Director provides regulatory expertise and guidance for labeling strategy , to deliver high quality ... CCDS and USPI documents for new products. + Solid understanding of pharmaceutical regulatory affairs , global labeling regulatory requirements and industry… more
- Bristol Myers Squibb (Madison, NJ)
- …careers.bms.com/working-with-us . **Position Responsibilities** + Leadership responsibility for global regulatory strategy to support the development of ... regulatory requirements by soliciting and integrating regional regulatory strategy liaison input. In collaboration with...with at least 4+ years of US Medical Device Regulatory Affairs experience **Key Competencies** + Experience… more
- AbbVie (Florham Park, NJ)
- …and Pipeline Commercial cross-functional teams and drives the development of medical affairs objectives aligned with strategy . + Provides input in design ... business strategy . International experience is a plus. Senior Scientific Director Qualifications: + Advanced Degree PhD or PharmD. Additional post doctorate… more
- AbbVie (Florham Park, NJ)
- … activities, generation and dissemination of data supporting the overall scientific strategy . + Responsible from Medical Affairs for the design, analysis, ... *Position title will be based on qualifications listed below. Purpose: The Director provides specialist medical and scientific strategic and operational input into… more
- Mallinckrodt Pharmaceuticals (Bridgewater, NJ)
- Job Title Director , Clinical Development and Medical Affairs (Respiratory) Requisition JR000014860 Director , Clinical Development and Medical Affairs ... Location Bridgewater, NJ Additional Locations Job Description Summary Job Description The Director of Clinical Development and Medical Affairs ( Respiratory)… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Marketing/ commercial + GMP QA/ Supply chain / Regulatory Affairs **Leadership/** **team** **management:** + ... rare diseases and immune disorders. **JOB SUMMARY** The Senior Director , Head Medical affairs Quality Assurance in...preparedness for the respective MA inspections in alignment with regulatory and company strategy . + Act as… 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
- Gilead Sciences, Inc. (Parsippany, NJ)
- …improve life by advancing the care of patients with life-threatening diseases. ** Director , Public Affairs , US HIV Prevention Communications & Media Relations** ... This role will work in partnership with the Sr Director in developing public relations strategies and tactics that...colleagues in the US Commercial organization, Clinical Development, Medical Affairs , Legal, and Government Affairs as well… more
- Ascendis Pharma (Princeton, NJ)
- …to grow and develop their skills. Ascendis Pharma is looking to hire an experienced Director , Regulatory Strategy and Policy Advisor to join our team. This ... join a rapidly growing innovative company. Position Summary The Director , Global Regulatory Strategy and...and Leadership team to develop and implement the Global Regulatory Affairs plan across all products, design… more
- Danaher Corporation (New York, NY)
- …& Scientific Affairs team and report to the lead medical director responsible for innovation, strategy , and evidence development and dissemination. If ... time and within budget. Work closely with internal teams such as clinical research, regulatory affairs , marketing, and sales to integrate medical affairs … more