- 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
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …+ Lead a multidisciplinary Global Regulatory Team (GRT) to develop global regulatory strategy and plans for assigned global projects. Gain endorsement from ... the product's lifecycle and across different indications. Represent Global Regulatory Affairs on the GPT (Global Project... risks, and opportunities in the development of global regulatory strategy and plans, considering therapeutic area… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …growth, thereby accomplishing corporate goals. **Responsibilities** + Develop and implement US regulatory strategy for assigned project(s). + Strategize and plan ... in the pharmaceutical industry preferred + 1 or More Years in regulatory affairs required + Experience in (s)NDA/BLA filing to FDA preferred **Travel** Ability… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …thereby accomplishing corporate goals. **Responsibilities:** + Develop and implement US regulatory strategy for assigned project(s). Strategize and plan for ... Years in the pharmaceutical industry required. + 8 or More Years in regulatory affairs + Experience in providing regulatory strategic input into the drug… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …+ 7 or More Years in the pharmaceutical industry + 4 or More Years in regulatory affairs , NDA, sNDA, BLA filing to FDA **Travel** Ability to travel up to ... and partner with FDA; direct, coordinate and implement the preparation of all regulatory submissions and provide regulatory support across all global projects,… more
- AbbVie (Florham Park, NJ)
- …YouTube and LinkedIn. Job Description The Director Regulatory Affairs , Strategic Labeling is responsible for setting strategy and leading ... 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)
- …researching on real-world evidence, and creating hope for all facing illness. The Director , Regulatory Affairs (Early Development) provides strategic global ... 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
- Merck (Rahway, NJ)
- **Job Description** The Regulatory Affairs Headquarters Principal Scientist is responsible for development and implementation of global regulatory ... point of contact on those projects within Global Regulatory Affairs and Clinical Safety (GRACS) and...(GRACS) and external to GRACS. + Develops worldwide product regulatory strategy to optimize label and obtain… 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
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …of assigned Regulatory Affairs team with emphasis on global regulatory strategy and the preparation, review, and submission of documents for FDA, ... for assigned cell and gene therapy portfolios. This role includes overseeing regulatory affairs staff, various outside contractors, supporting project teams 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 ... 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
- Insight Global (Florham Park, NJ)
- Job Description Insight Global is seeking an Associate Director of Regulatory Affairs to join the one of our pharmaceutical clients in Florham Park, NJ. This ... . Skills and Requirements 7+ years of experience with regulatory strategy in the US Background heavily focused on therapeutics Knowledge… more
- AbbVie (Florham Park, NJ)
- …medical and scientific strategic and operational input into core medical affairs activities such as: health-care professional and provider interactions; generation ... input into core brand (product) strategies, and to support medical affairs , marketing activities (promotional material generation and product launches) and market… more
- AbbVie (Florham Park, NJ)
- …Development and Pipeline cross-functional teams and drives the development of medical affairs objectives aligned with strategy . + Reviews, assesses and reports ... and scientific strategic and operational input into core medical affairs activities such as: healthcare professional/provider interactions (HCPs, Patients and… more
- Bayer (Whippany, NJ)
- …and category knowledge to US Medical Strategy , Marketing, New Development, US Regulatory Affairs , Communications, Legal and Global Medical Affairs for ... to make a real difference, there's only one choice.** ** Director Medical Affairs US Radiology (Breast)** The...press releases; + S/He will contribute to post approval regulatory required trials by the FDA. This position will… more
- Bristol Myers Squibb (Madison, NJ)
- …work and in their personal lives. Read more: careers.bms.com/working-with-us . The Associate Director , US Medical, Multiple Myeloma will report to the Director , ... medical support for a novel CELMoD asset and support for the asset medical strategy and book of work. This individual will be involved in executing an integrated… more
- AbbVie (Florham Park, NJ)
- …statistics, regulatory , etc.) as they relate to on-going medical affairs projects. + Experience in Neuroscience/Psychiatry preferred. + May assist as consultant ... be determined by the qualifications listed below. Purpose The Associate Scientific Director provides medical and scientific strategic and operational input into core… more
- City National Bank (New York, NY)
- * DIRECTOR BUSINESS AFFAIRS * *WHAT IS THE OPPORTUNITY?* This position provides overall management of significant City National Rochdale (CNR) projects on a ... the firm's activities ensuring that legal issues, contracts, disputes, and complex regulatory and operational risk activities are conducted within the due diligence… more
- Cypress Creek Renewables (New York, NY)
- Associate Director , State Affairs (East) at Cypress Creek Renewables (View all jobs) (https://ccrenew.com/careers/) New York or East Coast Remote The Company ... have a strong energy background, and experience with policy development, regulatory /legislative analysis, drafting, political strategy , and coalition building… more
- Organon & Co. (Jersey City, NJ)
- **Job Description** **The Position** Reporting to the Director or Executive Director in Organon Regulatory CMC New Products, the Associate Principal ... Scientist (Associate Director ) is responsible for Regulatory Chemistry Manufacturing...leading preparation and authorship of applicable IND/CTAs, Health Authority Regulatory CMC engagement strategy , Agency Background Packages,… more