- AbbVie (Florham Park, NJ)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Director Regulatory Affairs , Strategic Labeling is responsible ... or Microbiology + Preferred Education: Relevant Master's degree preferred. Certification in regulatory affairs a plus + Required Experience: 10+ years… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …evidence, and creating hope for all facing illness. The Director , Regulatory Affairs (Early Development) provides strategic global regulatory ... in the rare disease space. In this role, the Director defines and implements regulatory strategies; works...requests, and briefing documents. + Acts as liaison between Regulatory Affairs and other functional areas, including… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …researching on real-world evidence, and creating hope for all facing illness. The Senior Director , Regulatory Affairs - Clinical (Neuroderm), may be called ... upon to guide a team of Clinical Regulatory Affairs professionals providing strategic...to facilitate timely drug development and registration. The Senior Director , Regulatory Affairs - Clinical… more
- New York State Energy Research and Development Aut (New York, NY)
- …passion to work in a fast-paced environment on the cutting edge of energy policy. The Director , Legal and Regulatory Affairs will report directly to the NY ... Bank's Managing Director , Head of Legal and Regulatory Affairs and be charged with anticipating...mission of NYGB + Ability to balance legal and regulatory issues with the business and strategic … more
- New York State Energy Research and Development Aut (New York, NY)
- …advice and strategic counsel with respect to NYGB's operations, transactions, regulatory issues, and general corporate affairs . The MD-L&R must be committed ... to join its management team, lead its Legal & Regulatory Affairs ("LRA") team and provide legal...strategic counsel with respect to NYGB's operations, transactions, regulatory issues, and general corporate affairs . The… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …(RA Ad/Promo) is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner across cross-functional ... teams. RA Ad/Promo provides strategic regulatory guidance and input on Gilead's commercial and corporate...Experience working with external contractors supporting the work of regulatory affairs is a plus. + Experience… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …throughout the product's lifecycle and across different indications. + Represent Global Regulatory Affairs on the GPT (Global Project Team), Daiichi Sankyo ... Provide guidance to peers and cross-functional team members regarding strategic regulatory issues. + Develop timeline and...pharmaceutical industry + 7 or more years with direct regulatory affairs experience + Experience in … more
- 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 ... authorities' feedback, policies and guidelines. + Lead the development of regulatory strategic plans either directly in conjunction with project teams or through… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …of the submissions. Provides guidance to peers and cross-functional team members regarding strategic regulatory issues. Develops timeline and strategic input ... relevant pharmaceutical experience including 5 years of experience within Regulatory Affairs + Knowledge of IND, NDA/BLA...be preferred but not required. + Experience in providing regulatory strategic input into the Oncology drug… more
- Bristol Myers Squibb (Madison, NJ)
- …years in the industry with at least 4+ years of US Medical Device Regulatory Affairs experience **Key Competencies** + Experience in successfully leading teams; ... careers.bms.com/working-with-us . **Position Responsibilities** + Leadership responsibility for global regulatory strategy to support the development of biomarkers, companion… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …or More Years in regulatory affairs + Experience in providing regulatory strategic input into the drug development process with thorough knowledge of the ... with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development...will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory support… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …database to address external questions regarding drug products. The CMC Regulatory Associate Director , Biologics is responsible for content development, ... relevant lifecycle management projects driven by research. + Independently provide strategic guidance/input related to current regulatory requirements and… 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 ... serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic ...Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product labeling in collaboration… more
- AbbVie (Florham Park, NJ)
- …determined by the qualifications listed below. The Medical/Scientific Director , Medical Affairs - Psychiatry Pipeline is a strategic scientific expert with ... scientific and medical expertise to cross-functional teams, including research and development, regulatory affairs , market access, and commercial teams. + Ensure… more
- AbbVie (Florham Park, NJ)
- …Scientific Director , Psychiatry Pipeline role provides medical and scientific strategic and operational input into core medical affairs activities such ... data, value proposition). This role contributes significantly to key medical affairs strategic deliverables for assigned assets including comprehensive gap… more
- AbbVie (Florham Park, NJ)
- …guidelines and value proposition). Leads and holds accountability for core medical affairs strategic deliverables in a matrixed team environment including direct ... by the qualifications listed below. Purpose Provides specialist medical and scientific strategic and operational input into core medical affairs activities such… more
- AbbVie (Florham Park, NJ)
- …can sit in our Lake County, IL or Madison, NJ offices. The Scientific Director for US Medical Affairs in CNS/Psychiatry provides specialist medical and ... scientific strategic and operational input into core medical affairs activities such as: health-care professional and provider interactions; evidence generation… more
- Teva Pharmaceuticals (Parsippany, NJ)
- Director , Compliance & Ethics, Global R&D and Medical Affairs Date: Sep 6, 2024 Location: Parsippany, United States, New Jersey, 07054 Company: Teva ... **The opportunity** The Director Compliance & Ethics, Global R&D and Medical Affairs reports to the Global R&D Compliance Officer, with a dotted line reporting… more
- AbbVie (Florham Park, NJ)
- …remote candidates. Purpose: The Scientific Director provides medical and scientific strategic and operational input into core medical affairs activities such ... and safety surveillance activities). Works closely with commercial teams to provide strategic medical input into core brand (product) strategies, and to support… more
- AbbVie (Florham Park, NJ)
- …in Florham Park, NJ preferred. Will consider remote candidates. Purpose The Assistant Director , Medical Affairs has a key role within the Psychiatry Therapeutic ... to the specific asset or indication by providing scientific, strategic and operational input into core medical affairs...regulatory , etc.) as they relate to on-going medical affairs projects. + Ability to work effectively in a… more