- Taiho Oncology (Princeton, NJ)
- Associate Director , Regulatory Affairs Strategy Princeton, NJ, USA Req #415 Wednesday, November 27, 2024 Looking for a chance to make a meaningful difference ... in US and Europe. Position Summary: + Under the direction of regulatory affairs management, the incumbent independently prepares and directs global … more
- Novo Nordisk (Plainsboro, NJ)
- …for a living. Are you ready to make a difference? The Position The Associate Director , Regulatory Affairs - Advertising & Promotion will provide strategic ... Establish strong and positive working relationship with OPDP reviewers. Report to Senior Director , Regulatory Affairs - Advertising & Promotion. Essential… 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 ... Clinical Regulatory filings and provide regulatory leadership on...you if:** + If you bring strong understanding of US FDA and international pharmaceutical guidance, regulations, drug development… more
- Bristol Myers Squibb (Princeton, NJ)
- …BSN, etc.) with 5 years in the industry with at least 4+ years of US Medical Device Regulatory Affairs experience **Key Competencies** + Experience in ... **Working with Us ** Challenging. Meaningful. Life-changing. Those aren't words that... . **Position Responsibilities** + Leadership responsibility for global regulatory strategy to support the development of biomarkers, companion… more
- Merck (Rahway, NJ)
- **Job Description** The Global Regulatory Affairs and Clinical Safety Global Process Lead is responsible for overseeing and managing Global Regulatory ... maps, and risk management for global processes across Global Regulatory Affairs and Clinical Safety . The...in certain states and cities within the United States . Final determinations with respect to… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …leader will be responsible for bringing the issue and potential solutions to the Head of US Regulatory Affairs in conjunction with the assigned US RA ... accountable for ensuring consistent and transparent ways of working across the Alliance within US regulatory affairs and will work closely with the US … 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
- Insight Global (Basking Ridge, NJ)
- …robust development plans. The individual will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory ... Eastern Time Zone is preferred but not required. Responsibilities: Develop and implement US regulatory strategy for assigned project(s). Strategize and plan for… 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
- 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
- NJEDA (Newark, NJ)
- …Staff, Managing Director - Policy, Research, and Government Affairs , and Director - Legislative & Regulatory Affairs to develop positions and ... contributes to bill comments prepared by the Legislative & Regulatory Affairs team on proposed legislation that...Selected candidates must be authorized to work in the United States per the Department of Homeland… more
- Wells Fargo (New York, NY)
- …Fargo is seeking an Assistant General Counsel, Executive Director on our Public, Regulatory and Corporate Affairs Legal team to provide legal support on a ... of issues. This role will be in the Public Affairs section, which supports Public Affairs , including...membership or the equivalent in a country outside the United States **Desired Qualifications:** + Knowledge of… more
- Mallinckrodt Pharmaceuticals (Bridgewater, NJ)
- …for the clinical research aspects of registration activities with a working knowledge of regulatory affairs , in the development of the project strategy and the ... Job Title Senior Director , Clinical Development & Medical Affairs ...Affairs , Strategic Operations, Evidence Generation & Data Sciences, Regulatory Affairs , Pharmacovigilance) Strategy/Portfolio Management, Global Device… more
- City of New York (New York, NY)
- …Mayor's Office of Community Mental Health (OCMH) is seeking a Deputy Executive Director , External Affairs who will head the multidisciplinary External Affairs ... Director of OCMH and will directly manage 4 staff members.The Deputy Executive Director , External Affairs will work closely with the Executive Director … more
- Merck (Rahway, NJ)
- …with legal and compliance colleagues across the Offices of General Counsel- including with US Regulatory Legal and International Legal & Compliance teams - to ... **Job Description** **Job Scope** The Director , Corporate Affairs and Patient Innovation...in certain states and cities within the United States . Final determinations with respect to… more
- Bristol Myers Squibb (Madison, NJ)
- …pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with- us . The Medical Director , US Medical, Multiple Myeloma ... will report to the Senior Director , US Medical Multiple Myeloma Lead. He/she...Responsibilities** + Strategic and Tactical Planning: Responsible for the US Medical Affairs plans, in coordination with… more
- Abbott (Princeton, NJ)
- …executives, and scientists. **What You'll Work On** + Reporting directly to the Sr. Director , Global Medical & Scientific Affairs (GMSA), Abbott Point of Care + ... scientific dissemination of information + Cross-functional collaboration/interaction with Clinical Affairs , R&D, Regulatory , Quality, OEC, Legal, Global… more
- Taiho Oncology (Princeton, NJ)
- …functions at Taiho such as: Clinical Development, Commercial, HEOR, Market Access and Regulatory Affairs , Patient Advocacy, TOE, TPC and global teams to ensure ... Medical Director , Medical Affairs Princeton, NJ, USA...organization, and state-of-the-art facilities: these and other resources empower us to innovate and touch the lives of more… more
- LS Power Development, LLC (East Brunswick, NJ)
- …parental leave and more. **About the Role:** We currently have an opportunity for a Manager/ Director of Government Affairs that can be based in our New Jersey or ... **Overview** **About us :** Founded in 1990, LS Power is a...and advocacy strategies.As a member of LS Power's government affairs team, you will be responsible for designing and… more