- Regeneron Pharmaceuticals (Tarrytown, NY)
- 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)
- …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
- Regeneron Pharmaceuticals (Tarrytown, NY)
- Reporting to the Senior Director , Planning & Strategy for Regulatory Affairs , Global Patient Safety, and Development Quality (RA, GPS and DQ), the ... Director will be responsible for functional area support. **In...values of the Regeneron Way. _Key Internal Interfaces_ + Regulatory Affairs , Global Patient Safety, and Development… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …researching on real-world evidence, and creating hope for all facing illness. The Director , Regulatory Affairs 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
- 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 (Tarrytown, NY)
- …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
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …and immune disorders. **Summary:** Responsible for leading and developing global regulatory strategy for assigned development projects. Represents Daiichi ... strategy . + Responsible for ensuring aligned global regulatory strategy is endorsed by GPT and...relevant pharmaceutical experience including 5 years of experience within Regulatory Affairs + Knowledge of IND, NDA/BLA… more
- Bristol Myers Squibb (Madison, 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
- City of New York (New York, NY)
- … Director of OCMH and executive staff to set and execute the External Affairs strategy for the office. Additionally, the Deputy Executive Director will ... Community Mental Health (OCMH) is seeking a Deputy Executive Director , External Affairs who will head the...by directing and supporting the development of OCMH's media strategy to ensure clear and compelling updates to the… more
- Bayer (Whippany, NJ)
- …and category knowledge to US Medical Strategy , Marketing, New Development, US Regulatory Affairs , Communications, Legal and Global Medical Affairs for ... 832367 **Contact Us** **Email:** hrop_###@bayer.com **Job Segment:** Compliance, Radiology, Regulatory Affairs , Clinical Research, Medical Research, Legal,… 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
- 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
- Bayer (Whippany, NJ)
- …brilliant and diverse minds to make a real difference, there's only one choice.** ** Director US Medical Affairs Women's Healthcare** The Director US Medical ... based Candidate. **YOUR TASKS AND RESPONSIBILITIES** The primary responsibilities of this role, Director US Medical Affairs Women's Healthcare, are to: + Active… 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
- Bausch Health (Bridgewater, NJ)
- …your skills and values drive our collective progress and impact. As a Senior Director in Health Economics and Outcomes Research (HEOR), you will be responsible for ... building top-notch HEOR capabilities and implementing an HEOR strategy that is integrated and aligned with Product Development Plans (PDPs) and Clinical Development… more