- 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
- Sumitomo Pharma (Trenton, NJ)
- …be a key member of the Medical Affairs team reporting to the Executive Director , Medical Affairs Strategy . The job is responsible for developing the ... within SMPA and with alliance partners. + Oversee the strategy and development of Medical Affairs plans...**Compliance** : Achieve and maintain Compliance with all applicable regulatory , legal and operational rules and procedures, by ensuring… 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
- 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
- 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 (Princeton, 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
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …including working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub ... including working with contract manufacturing organizations CMO. This position develops strategy , prepares content templates and leads technical teams in preparation… 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
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …value and real-world evidence, US and global commercial teams, market access, and regulatory affairs , to ensure integrated global strategies and cohesive medical ... CNS TA which align to the broader overall TA strategy determined by the Sr. Director , Franchise...or early development (phase 1) assets either within Medical Affairs , Regulatory Affairs , or Clinical… more
- J&J Family of Companies (Horsham, PA)
- …for Medical Director , Dermatology to join our US Immunology Medical Affairs organization in** **Horsham, PA** . **Purpose:** As part of US Immunology Medical ... Affairs , the Medical Director , Dermatology, will serve...regulatory documents, as applicable. In addition, the Medical Director , Dermatology will partner with colleagues in real-world value… 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
- 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
- J&J Family of Companies (Horsham, PA)
- …and profoundly impact health for humanity. Learn more at https://www.jnj.com** **The Medical Director (MD), Medical Affairs , Prostate Cancer** **will serve as a ... impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Medical Affairs Group **Job Sub** **Function:** Medical Affairs - MD **Job… 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
- Cardinal Health (Trenton, NJ)
- …consulting services in a myriad of capacities, including: + Global Regulatory Strategy Development + Global Regulatory Affairs + Chemistry Manufacturing ... brand for post-approval success in obtaining the greatest market share possible. The Director , Business Development with Cardinal Health Regulatory Sciences is a… more
- Bristol Myers Squibb (Princeton, NJ)
- …and in their personal lives. Read more: careers.bms.com/working-with-us . **Associate Director , Global Regulatory Strategy , Neuroscience** **Position ... The selected candidate will have leadership responsibility for global regulatory strategy within a development team (DT)....PharmD, BSN, etc.) with at least 3+ years of Regulatory Affairs experience in the pharmaceutical industry.… more
- J&J Family of Companies (Horsham, PA)
- …Locations:** Horsham, Pennsylvania, United States of America **Job Description:** **Senior Director - Immunology Lifecycle Strategy & Marketing** Johnson & ... Johnson Innovative Medicine is recruiting for **a Senior** ** Director of Lifecycle Strategy ** located in Horsham, PA At Johnson & Johnson, we believe health is… more
- Bristol Myers Squibb (Princeton, NJ)
- …in their personal lives. Read more: careers.bms.com/working-with-us . Reporting to the Sr Director of WW Portfolio Strategy , this individual serves as the BMS ... MS with general knowledge of pharmaceutical operations, ie, advocacy, medical affairs , clinical development, regulatory , commercialization, + Understanding of… more
- Bristol Myers Squibb (Princeton, NJ)
- …with J&J alliance partners, cross-functionally + Partner with Clinical, Statisticians, Medical Affairs , Regulatory , Market Access and HEOR to ensure TPP is ... **Summary:** This position will play a central role in setting the strategy to successfully commercialize milvexian (FX1a) globally. A skilled leader and… more