- 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...you if:** + If you bring good understanding of US FDA and international pharmaceutical guidance, regulations, drug development… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …robust development plans. The individual will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory ... growth, thereby accomplishing corporate goals. **Responsibilities:** + Develop and implement US regulatory strategy for assigned project(s). Strategize and plan… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …+ 7 or More Years relevant pharmaceutical experience including experience within Regulatory Affairs + Understanding of scientific content and complexities and ... diseases and immune disorders. **Summary** Leadership responsibility for global regulatory strategy to support the development of biomarkers, companion diagnostic… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …More Years of relevant pharmaceutical experience including 5 years of experience within Regulatory Affairs + Knowledge of IND, NDA/BLA submission experience + ... and immune disorders. **Summary** Responsible for leading and developing global regulatory strategy for assigned development projects. Represents Daiichi Sankyo's … more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …More Years pharmaceutical industry experience required + 4 or More Years of direct regulatory affairs experience, including US labeling experience required + ... US or EU. Preparation of updated Core Data Sheets, and EU and US Documentation: Independently manages, prepares and implements regulatory documents (eg, USPI,… more
- Sanofi Group (Bridgewater, NJ)
- **Job title: Associate Director , US Advertising and Promotion, Global Regulatory Affairs ** + Location: Bridgewater, NJ or Cambridge, MA **About the job** ... The Associate Director , US Advertising and Promotion serves as the ...Ready to get started? **Main responsibilities:** + Represents Global Regulatory Affairs ( US RA AdPromo)… more
- Sanofi Group (Bridgewater, NJ)
- **Job title: Associate Director , US Advertising and Promotion, Global Regulatory Affairs ** + Location: Cambridge, MA or Bridgewater, NJ **About the job** ... The Associate Director , US Advertising and Promotion serves as the ... lead on Review Committees (RCs). As the RC Regulatory Affairs representative, work with brands on… more
- Mallinckrodt Pharmaceuticals (Bridgewater, NJ)
- … (CDMA) Requisition JR000014103 Senior Director , Clinical Development & Medical Affairs (CDMA) (Open) Location US Specialty Brand Headquarters - USA501 ... Additional Locations Bridgewater, NJ Job Description The Senior Director , Clinical Development Medical Affairs (CDMA) drives...aspects of registration activities with a working knowledge of regulatory affairs , in the development of the… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- … & Public Policy, this position will help lead Daiichi Sankyo's engagement across the United States to ensure patient access to our current portfolio and robust ... Affairs and Public Policy, develop, lead and prioritize Daiichi Sankyo's legislative and regulatory engagement and strategy in the states and DC, with a focus… more
- J&J Family of Companies (Raritan, NJ)
- Director , Global Medical Affairs Strategy and Execution, Specialty Ophthalmology - 2406188956W **Description** Johnson and Johnson Family is recruiting a ** ... data generation and dissemination strategies and projects, as outlined below: The Director , Global Medical Affairs Strategy and Execution will be responsible… more
- Bausch Health (Bridgewater, NJ)
- …effective aesthetic care options to consumers and physicians alike. The Professional Affairs lead is accountable for the designing & executing Solta's education ... with outstanding collaboration and teamwork with key partners such as, Medical Affairs , Marketing, Sales, Compliance, Quality, KOLs, etc. This role is responsible… more
- Sanofi Group (Bridgewater, NJ)
- …Bridgewater, NJ or Swiftwater, PA or Cambridge, MA **About the job** The Global Regulatory Affairs Device team is a globally diverse team supporting the medical ... **Job title: Device Regulatory Lead (Associate Director )** + Location:...of products. The team is part of the Global Regulatory Affairs , Regulatory CMC and… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …activities and ways of working. This role will also work with the Global Regulatory Affairs Leadership Team (GRA-LT) to define DS' priorities, strategy and ... collecting, analyzing, synthesizing and communicating intelligence relating to the US regulatory framework. ** Regulatory Policy**...Qualifications** + 7 or More Years Experience in pharma Regulatory Affairs , with at least 3 years… more
- J&J Family of Companies (Raritan, NJ)
- …East/Africa-Switzerland-Basel-Country-Allschwil, Europe/Middle East/Africa-Netherlands, Europe/Middle East/Africa-Switzerland, NA- United States , Europe/Middle ... East/Africa-Belgium-Antwerp-Beerse, NA- US -New Jersey-Raritan **Organization** Janssen Pharmaceutica NV (7555) **Job Function** Regulatory Affairs **Req ID:**… more
- J&J Family of Companies (Raritan, NJ)
- …to treatment and supports the interpretation and reporting of results. + Assists Regulatory Affairs in determining requirements for any corrective actions or ... team members. **OTHER RESPONSIBILITIES / DETAILED DUTIES:** + Assists Regulatory Affairs in the development of drug...in this posting applies to candidates hired in the United States . Candidates hired outside the … more
- J&J Family of Companies (Raritan, NJ)
- …and benefits information set forth in this posting applies to candidates hired in the United States . Candidates hired outside the United States will ... Director , Medical Safety Officer, Oncology - 2406183977W **Description**...Experience and knowledge of Good Clinical Practices and Pharmacovigilance regulatory requirements in US , the EU and… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. **Summary** The Senior Director , Head Global PV Quality (DSI/DSE) reports to the Global Head RDPVQA, ... key business function and collaborate with RD and Medical Affairs Quality to provide clinical safety QA advise wherever...preparedness for the respective PV inspections in alignment with regulatory and company strategy. + Act as the management… more
- J&J Family of Companies (Raritan, NJ)
- …Engagement: * Partner with cross-functional teams, including Clinical Development, Regulatory Affairs , Commercial Operations, and Market Access, Healthcare ... profoundly impact health for humanity. Learn more at https://www.jnj.com/. The Senior Director , Global Medical Affairs Operations Excellence will report directly… more
- Sanofi Group (Morristown, NJ)
- …and/or expectations of the Regulatory Authorities, in coordination with CHC US Regulatory Affairs , lead/co-lead the support of Health Authorities ... **Associate Director , Quality - US Consumer Healthcare...compliance with the CHC Global Quality standards and applicable US regulatory and GxP regulatory … more
- J&J Family of Companies (Raritan, NJ)
- …agreement, and maintenance of primary labeling (the Company Core Data Sheet (CCDS), United States Package Insert (USPI) and associated patient labeling, EU ... experience. + Relevant experience in the pharmaceutical industry (eg, Regulatory Affairs , Clinical, Medical Information, Pharmacovigilance) including at… more