- AbbVie (North Chicago, IL)
- …for future opportunities. The Director Regulatory Affairs Global Regulatory Lead, Global Regulatory Strategy , is responsible for developing and ... and content of global regulatory dossiers. + May lead the Labeling Regulatory Strategy Team (LRST), and serve as the primary regulatory interface with… 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)
- …+ Lead a multidisciplinary Global Regulatory Team (GRT) to develop global regulatory strategy and plans for assigned global projects. + Gain endorsement from ... product's lifecycle and across different indications. + Represent Global Regulatory Affairs on the GPT (Global Project... risks, and opportunities in the development of global regulatory strategy and plans, considering therapeutic area… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …growth, thereby accomplishing corporate goals. **Responsibilities** + Develop and implement US regulatory strategy for assigned project(s). + Strategize and plan ... in the pharmaceutical industry preferred + 1 or More Years in regulatory affairs required + Experience in (s)NDA/BLA filing to FDA preferred **Travel** Ability… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …thereby accomplishing corporate goals. **Responsibilities:** + Develop and implement US regulatory strategy for assigned project(s). Strategize and plan for ... Years in the pharmaceutical industry required. + 8 or More Years in regulatory affairs + Experience in providing regulatory strategic input into the drug… more
- AbbVie (Florham Park, NJ)
- …YouTube and LinkedIn. Job Description The Director Regulatory Affairs , Strategic Labeling is responsible for setting strategy and leading ... or Microbiology + Preferred Education: Relevant Master's degree preferred. Certification in regulatory affairs a plus + Required Experience: 10+ years… more
- AbbVie (North Chicago, IL)
- …LinkedIn. Job Description The Director Regulatory Affairs Global Regulatory Lead, Global Regulatory Strategy , is responsible for developing and ... and content of global regulatory dossiers. May lead the Labeling Regulatory Strategy Team (LRST). Serves as the primary regulatory interface with AST… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …researching on real-world evidence, and creating hope for all facing illness. The Senior Director , Regulatory Affairs - Clinical (Neuroderm), may be called ... practical, workable plans to facilitate timely drug development and registration. The Senior Director , Regulatory Affairs - Clinical also works directly with… more
- Philips (San Diego, CA)
- …regulatory strategies and quality team/QMS responsibilities. **Your role:** + Leading Regulatory Affairs strategy end-to-end execution (product inception ... The Director of Regulatory Affairs ...The Director of Regulatory Affairs & Quality will lead...on the management team. Be able to articulate compliant regulatory and quality strategy as well as… more
- Gilead Sciences, Inc. (Foster City, CA)
- …worldwide, with headquarters in Foster City, California. **About the Role:** The Senior Director , CMC Regulatory Affairs for Biologics is responsible for ... in Gilead's global portfolio of biological products in CMC Regulatory Affairs . This position will provide leadership...the projects they are responsible for have a cohesive regulatory strategy that is integrated into Pharmaceutical… more
- 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...years of pharmaceutical industry experience in developing and implementing regulatory submissions strategy for early and late… more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. As an Associate Director , Global Regulatory Affairs Marketed Products you will define, ... regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively… more
- Abbott (Alameda, CA)
- …diversity, working mothers, female executives, and scientists. **The Opportunity** This **Associate Director Regulatory Affairs - APAC** will work on-site ... Division. As a manager, the function of an Associate Director Regulatory Affairs , APAC (Asia... considerations into the APAC product entry and exit strategy . + Recruit, develop and manage regulatory … more
- Gilead Sciences, Inc. (Foster City, CA)
- …exciting opportunity within our US Medical Affairs (USMA) Liver team for a Director , Medical Affairs Strategy for Primary Biliary Cholangitis (PBC). This ... based in Foster City, CA. Reporting to the Senior Director US Medical Affairs (USMA) Liver -...projects. + Partner cross functionally with Legal, Commercial, Clinical, Regulatory , Public and Government Affairs , to lead… more
- Stryker (San Jose, CA)
- …(https://d25zu39ynyitwy.cloudfront.net/oms/000000/document/2024/6/SMVZW\_USStrykerEmployeebenefits/USStrykerEmployeebenefits.pdf) The ** Director , Regulatory ... Affairs ** is a key strategist, responsible for developing regulatory strategy for the **Endoscopy business unit** and delivering Stryker's best-in-class… more
- Gilead Sciences, Inc. (Foster City, CA)
- …possible, together. **Job Description** We are looking for a highly motivated Medical Affairs Associate Director who is passionate about HIV prevention and ... Director will report to the US HIV Prevention Strategy Lead and will work directly with the US...trainings + Partner cross functionally with Legal, Commercial, Clinical, Regulatory , Public and Government Affairs , to support… more
- Abbott (Alameda, CA)
- …diversity, working mothers, female executives, and scientists. **The Opportunity** This **Associate Director Regulatory Affairs - US New Product Introduction ... area or law is helpful. + Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.) + Previous experience with 510k / PMA / DeNovo… more
- Gilead Sciences, Inc. (Foster City, CA)
- …possible, together. **Job Description** We are looking for a highly motivated Medical Affairs Director who is passionate about HIV prevention and Pre-exposure ... products, with a focus on injectable PrEP. The Medical Affairs Director , HIV Prevention, will report directly...training + Partner cross functionally with Legal, Commercial, Clinical, Regulatory , and Public and Government Affairs , to… more
- New York State Energy Research and Development Aut (New York, NY)
- …senior attorney (the "MD-L&R") to join its management team, lead its Legal & Regulatory Affairs ("LRA") team and provide legal advice and strategic counsel with ... for overseeing and being directly responsible for a variety of legal and regulatory affairs activities and deliverables at the highest level of industry… more
- Gilead Sciences, Inc. (Foster City, CA)
- …35 countries worldwide, with headquarters in Foster City, California. **Job Overview:** The Executive Director (ED) USMA Strategy - HIV Treatment is a key member ... role is responsible for developing and driving the USMA Strategy and annual medical planning for HIV Treatment and...US Government Affairs and Policy, US Public Affairs , US Regulatory , and US legal and… more