- Taiho Oncology (Princeton, NJ)
- Associate Director , Regulatory Affairs Operations Pleasanton, CA, USA * Princeton, NJ, USA Req #386 Tuesday, August 20, 2024 Looking for a chance to make a ... expanding mid-size oncology company in the role of Associate Director , Regulatory Affairs Operations where... Operations team by providing guidance, as well as regulatory system and process support for the US… 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
- Ascendis Pharma (Princeton, NJ)
- …We offer a dynamic workplace for employees to grow and develop their skills. The Regulatory Affairs (RA) Associate Director , Labeling will be responsible for ... biopharmaceutical company with locations in Denmark, Europe, and the United States . Today, we're advancing programs in...Labeling will be overall responsible for ensuring compliance with US regulatory requirements for labeling, and for… 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 ... 7,000 employees share a common goal and values, propelling us to provide essential care to millions of people...promotion review experience. Broad knowledge of the pharmaceutical industry Regulatory Affairs discipline for prescription drugs. +… 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
- 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
- Canon USA & Affiliates (Trenton, NJ)
- …Track pending FDA submissions (510's, PMA's), IDE, and IRB. + Serve in lieu of the Director Regulatory Affairs as required. + Position will work in PST ... for pre-market and post-market activities as assigned by the Director , Regulatory Affairs to include...plus performance incentive with upside potential. \#LI-RS1 \#LI-Remote **_About us !_** _Canon Medical Systems USA, Inc., a world leader… more
- J&J Family of Companies (Skillman, NJ)
- …Associate, Regulatory Affairs , Dietary Supplements This position reports to the Director , Regulatory Affairs and is based in Skillman. **Who we are** ... not be discriminated against on the basis of disability. \#VHD **Primary Location** NA- US -New Jersey-Skillman **Job Function** Regulatory Affairs **Req ID:**… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …throughout the product's lifecycle and across different indications. + Represent Global Regulatory Affairs on the GPT (Global Project Team), Daiichi Sankyo ... for providing oversight and formulation of strategy for global regulatory submissions in Oncology in the US ,...pharmaceutical industry + 7 or more years with direct regulatory affairs experience + Experience in … 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
- Bristol Myers Squibb (Princeton, NJ)
- …goals, both at work and in their personal lives. Read more: careers.bms.com/working-with- us . The GRS-CMC organization provides regulatory expertise related to ... **Working with Us ** Challenging. Meaningful. Life-changing. Those aren't words that...to address external questions regarding drug products. The CMC Regulatory Associate Director , Biologics is responsible for… 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
- J&J Family of Companies (Titusville, NJ)
- …& Johnson Innovative Medicine is recruiting for Associate Director , North America Regulatory Lead in Global Regulatory Affairs , supporting programs in ... At Johnson & Johnson, we all belong. The Associate Director , Regulatory Affairs will be...in this posting applies to candidates hired in the United States . Candidates hired outside the … more
- J&J Family of Companies (Titusville, NJ)
- …of 2) - 2406184564W **Description** Johnson & Johnson Innovative Medicine is recruiting for a Director , Global Regulatory Affairs Leader (1 of 2) located in ... Director , Global Regulatory Leader (GRL) (1...authority regulated industry + At least 6 years of Regulatory Affairs experience required with focus on the… more
- J&J Family of Companies (Skillman, NJ)
- …RA Dietary Supplements - 2407024953W **Description** Kenvue is currently recruiting for: Director , Regulatory Affairs , Dietary Supplements This position ... reports to the Senior Director , Regulatory Affairs and is...disability. **Primary Location** NA- US -New Jersey-Union **Other Locations** NA- US -New Jersey-Skillman **Job Function** Regulatory Affairs… more
- Novo Nordisk (Princeton, NJ)
- …personnel. Relationships Report to the Director /Associate Director /Lead Regulatory Scientist/Sr. Manager Regulatory Affairs . Develop and maintain ... positive rapport and working relationships with other personnel in Regulatory Affairs , CMR, and other local and...documents such as cover letters, pre-meeting package, and other US specific regulatory positioning documents to assist… more
- Cardinal Health (Trenton, NJ)
- …education for healthcare professionals, patients and others. This role reports to the Director of Regulatory & Medical Affairs . **Responsibilities:** + ... course work in applicable field highly preferred + Current working knowledge of US legal, regulatory , and compliance regulations & guidelines to industry… more
- CVS Health (Trenton, NJ)
- …active license to practice medicine in a State, Territory, Commonwealth of the United States , or the District of Columbia * Required annual Continuing ... Bring your heart to CVS Health. Every one of us at CVS Health shares a single, clear purpose:...4 company, has an outstanding opportunity for a Medical Director - Medical Affairs . We need a… more
- Abbott (Princeton, NJ)
- …operational performance. Our location in Princeton, NJ currently has an opportunity for a Director of Medical Affairs , Americas. The Director of Medical ... executives, and scientists. **What You'll Work On** + Reporting directly to the Sr. Director , Global Medical & Scientific Affairs (GMSA), Abbott Point of Care +… more