- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Associate 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… more
- Bristol Myers Squibb (Madison, NJ)
- …lives. Read more: careers.bms.com/working-with-us . **Summary:** The role of Associate Director of US Commercial Regulatory Affairs requires the ability ... to apply complex scientific and expert regulatory advice and risk assessment for the development of...risk assessment and mitigation strategies to Commercial Teams, Medical Affairs , Public Affairs , Value Access and Payment,… more
- Sanofi Group (Bridgewater, NJ)
- About the Role The Associate Director , US Regulatory Affairs (RA) serves as the regulatory lead on relative Review Committees (RCs), for products in ... of prescription drugs and biologics. Essential Functions + Represents Global Regulatory Affairs (US RA AdPromo) as a member of cross-functional brand and… 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 ... + Experience working with external contractors supporting the work of regulatory affairs is a plus. + Experience authoring and/or implementing processes. +… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …pharmaceutical industry experience required + 4 or More Years of direct regulatory affairs experience, including US labeling experience required + Experience ... This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product… more
- Sanofi Group (Bridgewater, NJ)
- The Associate Director RA serves as the regulatory lead on Review Committees (RCs). As the RC RA representative, work with brands on competitively ... + This individual is expected to competently and confidently represent Regulatory Affairs as a key member of cross-functional RC teams for assigned,… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …of patients with life-threatening diseases. We have an exciting opportunity within US Medical Affairs for an Associate Director in our Patient Access and ... Director , Strategy Lead of PAQ Virology. The Associate Director of Medical Affairs ...the US healthcare landscape. + Solid working knowledge of regulatory and compliance environment. + Effective organizational, project planning,… more
- Sanofi Group (Bridgewater, NJ)
- …pharmaceutical/biotechnology industry experience, including at least 4 years of relevant Regulatory Affairs experience (regionally and/or global) especially in ... **Main responsibilities:** + Leads the US regulatory activities. + As a key member of the Global Regulatory Team (GRT), and strategic partner to the Global … more
- Sanofi Group (Bridgewater, NJ)
- …pharmaceutical/biotechnology industry experience, including at least 4 years of relevant Regulatory Affairs experience (regionally and/or global) especially in ... team** The team is involved in developing and executing regulatory strategies for Tzield in life cycle development stages...a later diagnosis. **Main responsibilities:** + Leads the US regulatory post-marketing activities. + As a key member of… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. **Summary** The Associate Director , RACMC Portfolio Products, will be responsible for ... with cross functional teams and various departments to include Marketing, Medical Affairs , Regulatory Affairs , Supply Chain Technical Operations,… more
- Sanofi Group (Bridgewater, NJ)
- About the job - US Medical Associate Director , Respiratory **Our Team:** This position will report into the US Medical Immunology team which is a segment of the ... Medical Affairs Specialty Care organization. Our Medical Affairs ...serves as a valued strategic partner with Clinical, Commercial, Regulatory , and Market Access on therapeutic solutions to support… more
- Sanofi Group (Bridgewater, NJ)
- …into the Global Medical Immunology team that is part of the Medical Affairs Specialty Care organization. Our Medical function serves as a key strategic partner ... with commercial, regulatory , clinical, and market access on therapeutic solutions to...solutions to support patients' needs. Within the Global Medical Affairs Immunology team, we are proud to support Sanofi's… more
- Sanofi Group (Bridgewater, NJ)
- …gastrointestinal diseases. **Main Responsibilities:** The Global Medical Immunology Pipeline Associate Director , Gastroenterology, reports to the Global Medical ... clinical care. We curate patient and scientific evidence and partner with commercial, regulatory , R&D, market access, and external affairs teams to develop… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders. **SUMMARY** + The Associate Director , Pharmacoepidemiology position provides epidemiologic, methodological, and ... study protocols. + This position independently manages relationships with internal (CSPV, Regulatory , Clinical, Medical Affairs , HEOR and other stakeholders to… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …include: Clinical Operations, Clinical Development, Biostatistics and Data Management, Regulatory Affairs , Quantitative Clinical Pharmacology, Clinical Safety ... and Pharmacovigilance, Regulatory /Risk Management, Quality Assurance, Medical Affairs , Translational Research, Research, Informatics Services, Project Management and… more
- Sanofi Group (Bridgewater, NJ)
- Digital Product Owner (Associated Director ) Incentive Compensation (IC) works in a worldwide team accountable for the definition, design, evolution, delivery, and ... ecosystem including sales force excellence, customer engagement, R&D, and field medical affairs . In the role of Product Owner IC, he/she delivers the proper… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Liasions to ensure sucessful implementation of CDx and data collection + Supports Regulatory affairs in providing content and providing review of documents ... + Creates a forward-looking Diagnostic development strategy while keeping abreast of regulatory and policy updates in the external environment and by tracking and… more
- AbbVie (Branchburg, NJ)
- …with multiple driver indications within a Therapeutic Area and supports the Manager (Global Regulatory Lead (GRL), Associate Director , Director , or ... of global regulatory strategy and representation of Regulatory Affairs on R&D project teams. Assures...Director ), in the development and execution of the regulatory strategy. Assigned matters may have a moderate impact… more
- AbbVie (Madison, NJ)
- …with multiple driver indications within a Therapeutic Area and support the Manager, Global Regulatory Lead (GRL), Associate Director , or Director , in ... . Advise internal customers who may contribute to regulated communication on Regulatory /FDA issues including Public Affairs , Clinical Development, Legal, and… more