- Merck (Rahway, NJ)
- **Job Description** We are seeking a Director (Principal Scientist), Global Regulatory Affairs Liaison with a visionary, growth-oriented mindset that can ... advance our pipeline and drive our strategic priorities. The Director , Principal Scientist | Regulatory Affairs...and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …ensuring appropriateness throughout the product's lifecycle and across different indications. Represent Global Regulatory Affairs on the GPT ( Global ... responsible for providing oversight and formulation of strategy for global regulatory submissions in Oncology in the...pharmaceutical industry + 7 or More Years with direct regulatory affairs experience, including experience in … more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …7 or More Years in the pharmaceutical industry preferred + 4 or More Years in regulatory affairs , NDA, sNDA, BLA filing to FDA preferred **Travel:** + Ability to ... preparation of all regulatory submissions and provide regulatory support across all global projects, securing the cooperation of others (team members); meet… more
- Merck (Rahway, NJ)
- …Description** We are seeking a Senior Director (Sr. Principal Scientist) Global Regulatory Affairs Liaison with a visionary, growth-oriented mindset ... and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical...external to GRACS. **Key Functions** + Reports to Executive Director or Associate Vice President, General Medicine + Works… more
- AbbVie (Florham Park, NJ)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Director Regulatory Affairs , Strategic Labeling is responsible for ... and product labeling (CCDS, US/EU labeling documents) at Senior level meetings ( Global Regulatory Forum (GRF), Executive Labeling Committee (ELC), Steering… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …on real-world evidence, and creating hope for all facing illness. The Director , Regulatory Affairs provides strategic global regulatory guidance to ... and guidelines. + Leads as a key member of Global Regulatory Project Teams. + Leads multidisciplinary...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 ... to facilitate timely drug development and registration. The Senior Director , Regulatory Affairs - Clinical...Global Regulatory Project Teams; and represents Regulatory Affairs on various other process and… more
- Teva Pharmaceuticals (Parsippany, NJ)
- Director , Compliance & Ethics, Global R&D and Medical Affairs Date: Oct 5, 2024 Location: Parsippany, United States, New Jersey, 07054 Company: Teva ... **The opportunity** The Director Compliance & Ethics, Global R&D and Medical Affairs reports to...will leverage in-depth expertise and knowledge of the industry's legal/ regulatory environment in order to provide clear, concise and… 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 ... York is leading the nation in the fight on global climate change and the transition to a clean...Bank's Managing Director , Head of Legal and Regulatory Affairs and be charged with anticipating… more
- Bausch Health (Bridgewater, NJ)
- …and procedures to enhance efficiencies and compliance. + Works closely with the Regulatory Affairs labeling group regarding package insert changes to assess and ... Join a team! We are a global diversified pharmaceutical company enriching lives through our...promotion review experience. Broad knowledge of the pharmaceutical industry Regulatory Affairs discipline for prescription drugs. +… more
- New York State Energy Research and Development Aut (New York, NY)
- …senior attorney (the "MD-L&R") to join its management team, lead its Legal & Regulatory Affairs ("LRA") team and provide legal advice and strategic counsel with ... York is leading the nation in the fight on global climate change and the transition to a clean...being directly responsible for a variety of legal and regulatory affairs activities and deliverables at the… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …Regulatory Advertising and Promotion (RA Ad/Promo) is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical ... or other special projects. May initiate and/or contribute to global process improvements. + Provides regulatory guidance...Experience working with external contractors supporting the work of regulatory affairs is a plus. + Experience… more
- Bristol Myers Squibb (Madison, NJ)
- …more: careers.bms.com/working-with-us . **Position Responsibilities** + Leadership responsibility for global regulatory strategy to support the development of ... + Ensure global development plans will meet global regulatory requirements by soliciting and integrating...with at least 4+ years of US Medical Device Regulatory Affairs experience **Key Competencies** + Experience… more
- 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
- Bristol Myers Squibb (New Brunswick, NJ)
- …through all stages of a products lifecycle. Members of the organization develop global regulatory CMC strategies and partners with key stakeholders to execute ... to address external questions regarding drug products. The CMC Regulatory Associate Director , Biologics is responsible for..., Biologics will serve as the primary interface between Global Regulatory Sciences (GRS) and Global… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …or More Years in the pharmaceutical industry required. + 8 or More Years in regulatory affairs + Experience in providing regulatory strategic input into the ... preparation of US regulatory submissions and provide US regulatory support across all global projects; meet aggressive deadlines to ensure that regulatory… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …More Years in the pharmaceutical industry preferred + 1 or More Years in regulatory affairs required + Experience in (s)NDA/BLA filing to FDA preferred ... preparation of US regulatory submissions and provide US regulatory support across all global projects; meet aggressive deadlines to ensure that regulatory… more
- AbbVie (Florham Park, NJ)
- …with the scientific review, development, approval, execution, and communication of affiliate/area/ global medical affairs sponsored or supported clinical research ... the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. + Responsible… more
- AbbVie (Florham Park, NJ)
- …understanding of relevant therapeutic area required. + 7-10 years of experience in Medical Affairs with Global Medical Affairs experience highly preferred. + ... and scientific strategic and operational input into core medical affairs activities such as: healthcare professional/provider interactions (HCPs, Patients and… 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 ... with the scientific review, development, approval, execution, and communication of affiliate/area/ global medical affairs sponsored or supported clinical research… more