- Merck (Rahway, NJ)
- …and solutions to the world. **Looking for someone with a growth mindset. The Director , Regulatory Affairs Liaison is responsible for:** + Developing ... **Job Description** Our Regulatory Affairs team bring new medical...but are not limited to:** + Reports to Executive Director or Associate Vice President, Therapeutic Area Lead. +… 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
- Mitsubishi Chemical Group (Jersey City, NJ)
- …to marketed products in US and Canada. In addition, the Senior Director , Commercial Regulatory Affairs , in collaboration with Head, Regulatory ... unmet medical needs in North American markets. In the United States , MTPA launched rare diseases treatments...and creating hope for all facing illness. The Senior Director , Commercial Regulatory Affairs , is… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …aspirations. Join Gilead and help create possible, together. **Job Description** As a Director , Global Regulatory Affairs , Precision Medicine you will ... need to work closely with the Vice President, Global Regulatory Affairs Oncology and Precision Medicine, and...conditions of the applicable plans. **For jobs in the United States :** As an equal opportunity employer,… 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 ... Bank's Managing Director , Head of Legal and Regulatory Affairs and be charged with anticipating...or university and admitted to practice law in a US jurisdiction for at least eight years. If bar… more
- Bausch Health (Bridgewater, NJ)
- …and regulatory agency guidance. Responsibilities: + Manages or represents Regulatory Affairs on the promotional review committees for prescription products ... interprets new regulations, guidance documents and enforcement letters. Updates the Regulatory Affairs advertising and promotion staff, review committees and… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …their aspirations. Join Gilead and help create possible, together. **Job Description** Regulatory Affairs Labeling is a core function within Gilead's Global ... Regulatory Affairs organization and acts as a...conditions of the applicable plans. **For jobs in the United States :** As an equal opportunity employer,… 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 ... and promotion review experience. Broad knowledge of the pharmaceutical industry Regulatory Affairs discipline for prescription drugs. + Detail-oriented with… 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 ... objectives. This group also represents Gilead's commercial activities to US regulatory agencies. You will manage the...conditions of the applicable plans. **For jobs in the United States :** As an equal opportunity employer,… 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
- Merck (Rahway, NJ)
- **Job Description** Our Diagnostics focused Regulatory Affairs team helps bring new precision medicine advancements to the world by facilitating effective, ... in diagnostics and/or medical devices, the majority of which must be in diagnostic regulatory affairs . Preferred: MS with minimum of 8 years of relevant … 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… 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
- Sanofi Group (Bridgewater, NJ)
- **Job title: Associate Director , US Advertising and Promotion, Global Regulatory Affairs ** + Location: Bridgewater, NJ or Cambridge, MA **About the job** ... The Associate Director , US Advertising and Promotion serves as the ...Ready to get started? **Main responsibilities:** + Represents Global Regulatory Affairs ( US RA AdPromo)… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …with life-threatening diseases. We have an exciting opportunity within US Medical Affairs for an Associate Director in our Patient Access and Quality of ... PAQ Virology. The Associate Director of Medical Affairs - PAQ Virology will support the US...conditions of the applicable plans. **For jobs in the United States :** As an equal opportunity employer,… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …where they live or their economic status. ** Director US Oncology Patient Advocacy, US Public Affairs ** Reporting to the Senior Director of US ... partners will include, but not be limited to: Public Affairs , Medical Affairs , Clinical Research, Regulatory...long-term, trusting relationships with patient advocacy organizations in the United States * Coordinate Gilead's funding and… more
- Mallinckrodt Pharmaceuticals (Bridgewater, NJ)
- … (CDMA) Requisition JR000014103 Senior Director , Clinical Development & Medical Affairs (CDMA) (Open) Location US Specialty Brand Headquarters - USA501 ... Additional Locations Bridgewater, NJ Job Description The Senior Director , Clinical Development Medical Affairs (CDMA) drives...aspects of registration activities with a working knowledge of regulatory affairs , in the development of the… more
- AbbVie (Florham Park, NJ)
- …scientific and medical expertise to cross-functional teams, including research and development, regulatory affairs , market access, and commercial teams. + Ensure ... be determined by the qualifications listed below. The Medical/Scientific Director , Medical Affairs - Psychiatry Pipeline is...compliance with regulatory and ethical standards in all medical … more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- … & Public Policy, this position will help lead Daiichi Sankyo's engagement across the United States to ensure patient access to our current portfolio and robust ... Affairs and Public Policy, develop, lead and prioritize Daiichi Sankyo's legislative and regulatory engagement and strategy in the states and DC, with a focus… more