- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …disorders. Summary This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational ... leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This position may...experience required + 4 or More Years of direct regulatory affairs experience, including US labeling experience… more
- Sanofi Group (Bridgewater, NJ)
- …families. Your skills could be critical in helping our teams accelerate progress. The Director , Global Regulatory Affairs (GRA)-Advertising and Promotion ... This role is responsible for overseeing several activities for Global A-P including but not limited to: + Lead...initiatives and associated cross-functional teams + Lead GRA A-P regulatory deliverables in support of technology evolution, and Gen… 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...and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical… more
- Merck (Rahway, NJ)
- …, Business Development Execution, The primary function includes coordinating various GRACS ( Global Regulatory Affairs and Clinical Safety) functional areas, ... to ensure implementation and maintenance of regulatory activities associated with assigned Company Business Development (BD) Agreements. These agreements include but… more
- Novo Nordisk (Plainsboro, NJ)
- …inclusive culture within our One Development organization. Relationship Reports to the Executive Director Global Medical Affairs East Coast Hub. Will ... ready to make a difference? The Position The Associate Global Medical Director will serve as a... Research, Global Development, Market Access, Marketing, Regulatory Affairs , Safety, International Operations, Regions &… more
- Novo Nordisk (Plainsboro, NJ)
- …inclusive culture within our One Development organization. Relationship Reports to the Executive Director Global Medical Affairs East Coast Hub. Will ... ( Global Research, Global Development, Market Access, Marketing, Regulatory Affairs , Safety, International Operations, Regions & Affiliates, NN… more
- J&J Family of Companies (Raritan, NJ)
- …step of the way. Learn more at https://www.jnj.com/innovative-medicine We are seeking a Director , Global Medical Affairs Strategy & Execution in Oncology. ... Primary Responsibilities include, but are not limited to: The Director , Global Medical Affairs Strategy...Medical Affairs directors, Janssen R&D clinical scientists, global and regional marketing directors, regulatory leaders,… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …. Brings issues with regard to ways or working or resources to the Head of US Regulatory Affairs and/or Global Regulatory Lead for asset to reach ... issue and potential solutions to the Head of US Regulatory Affairs in conjunction with the assigned...resolution. + Participate in global product team meetings to provide US … more
- Bausch Health (Bridgewater, NJ)
- …it-where your skills and values drive our collective progress and impact. The Associate Director , Regulatory Affairs handles regulatory development and ... assigned pharmaceutical products. + Coordinate/Liaise with BHC country-specific pharmaceutical Regulatory Affairs personnel for international submissions and… more
- Bausch Health (Bridgewater, NJ)
- …drive our collective progress and impact. Responsibilities: + Manages or represents Regulatory Affairs on the US promotional review committees for prescription ... Ad/Promo staff under the direction of the Executive Director , Regulatory Advertising & Promotion. + Provides...of market promotional and advertising strategies. + Updates the Regulatory Affairs advertising and promotion staff, review… more
- Sanofi Group (Morristown, NJ)
- **Job title** : Director , US Regulatory Affairs ...area, you will be considered the resident expert in Global Regulatory Affairs Region NA, ... and direct reports. + In conjunction with the Sr. Director /Product Support Head, imparts senior regulatory guidance...8+ years of experience within pharmaceutical or medical device Regulatory Affairs + Successful track record of… more
- AbbVie (Branchburg, NJ)
- …YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Associate Director , Regulatory Affairs US Advertising and Promotion is ... 6 years of relevant industry experience. Certification a plus + Experience in US Regulatory Affairs Advertising and Promotion preferred + Experience working in a… 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
- BlackRock (New York, NY)
- …retirement, energy security, financial technology, and critical infrastructure. This role is for a Director of Regulatory Affairs on the US Government ... 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
- 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)
- …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)
- …+ 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 ... preparation of all regulatory submissions and provide regulatory support across all global projects, securing the cooperation of others (team members); meet… 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 ... Join a team! We are a global diversified pharmaceutical company enriching lives through our...our collective progress and impact. Responsibilities **:** + Provides regulatory review of advertising and promotional materials, new campaigns… more
- Amneal Pharmaceuticals (Piscataway, NJ)
- …to department and company goals and objectives. Essential Functions: + Develop and Execute Global Regulatory Strategies: Formulate and lead global CMC and ... including preparing briefing books, planning rehearsals, and risk mitigation. Represent Global Regulatory on cross-functional teams to address regulatory… 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