- Merck & Co. (Rahway, NJ)
- Job DescriptionWe are seeking a Director (Principal Scientist), Global Regulatory Affairs Liaison with a visionary, growth-oriented mindset that can help ... advance our pipeline and drive our strategic priorities.The Director , Principal Scientist - Regulatory Affairs...in certain states and cities within the United States . Final determinations with respect to… more
- Daiichi Sankyo, Inc. (Bernards, 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. (Bernards, NJ)
- …robust development plans. The individual will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory ... the company's growth, thereby accomplishing corporate goals.Responsibilities:Develop and implement US regulatory strategy for assigned project(s). Strategize and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …More Years pharmaceutical industry experience required4 or More Years of direct regulatory affairs experience, including US labeling experience ... US or EU. Preparation of updated Core Data Sheets, and EU and US Documentation: Independently manages, prepares and implements regulatory documents (eg, USPI,… more
- Merck & Co. (Rahway, NJ)
- …a cross-functional Senior/ Executive Director group of experts in commercialization, regulatory affairs , statistics, medical affairs and manufacturing to ... to provide the safety and efficacy data required for regulatory approval of potential new drugs and new indications...in certain states and cities within the United States . Final determinations with respect to… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur company in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines, and ... closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage...in certain states and cities within the United States . Final determinations with respect to… 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
- BlackRock (New York, NY)
- …technology, and critical infrastructure. This role is for a Director of Regulatory Affairs on the US Government Affairs & Public Policy team ... policymakers around the world on financial markets policy. Since 2009, the Government Affairs & Public Policy team has steadily established the firm as a respected… more
- Bausch Health (Bridgewater, NJ)
- …and values drive our collective progress and impact. Responsibilities: + Manages or represents Regulatory Affairs on the US promotional review committees for ... to assure that all advertising and promotional materials follow US regulatory requirements and Company policies. +...of market promotional and advertising strategies. + Updates the Regulatory Affairs advertising and promotion staff, review… more
- Bausch Health (Bridgewater, NJ)
- …helps lead the company in discussions with OPDP. + Works closely with the Regulatory Affairs labeling group regarding package insert changes to assess and ... international pharmaceuticals. Our 7,000 employees share a common goal and values, propelling us to provide essential care to millions of people globally. We seek… 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
- 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 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
- Mount Sinai Health System (New York, NY)
- **Job Description** The Assistant Director will oversee the regulatory component of the human research protection program at Mount Sinai. Responsible for all ... regulatory knowledge relating to human research, including federal, state,...research community. + Handle special projects/investigations as requested. **About Us ** **Strength through Unity and Inclusion** The Mount Sinai… more
- System One (Florham Park, NJ)
- Job Title: Director , US Regulatory Affairs Location: Florham Park, NJ (50% hybrid) Type: contract Overview: Support the Global Therapeutic Area Lead ... (GTAL), Regulatory Affairs (Senior Director ) in developing and executing regulatory strategies for antimicrobial/ antifungal programs globally or within… more
- Sanofi Group (Bridgewater, NJ)
- …Your skills could be critical in helping our teams accelerate progress. The Director , Global Regulatory Affairs (GRA)-Advertising and Promotion (A-P) ... initiatives and associated cross-functional teams + Lead GRA A-P regulatory deliverables in support of technology evolution, and Gen...about sensitive data **Languages** : + English **Why Choose Us ?** + Bring the miracles of science to life… more
- 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...in certain states and cities within the United States . Final determinations with respect to… 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
- 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
