- DivIHN Integration Inc (Chicago, IL)
- …yrs) Primary Job Function: Supports Global Director of Medical and Scientific Affairs to defining medical affairs strategy and conduct medical activities ... the following responsibilities under the supervision of the Global Director of Medical and Scientific affairs : Functions...to give input on clinical trials. Meet with the regulatory team About us: DivIHN, the 'IT Asset Performance… more
- Taiho Oncology (Pleasanton, CA)
- Sr. Director , Regulatory Affairs Strategy Pleasanton, CA, USA Req #356 Friday, March 29, 2024 Looking for a chance to make a meaningful difference in the ... for Japan and Asia. For assigned projects and products, the Senior Director , Regulatory Affairs Strategy is responsible for strategic… more
- Teva Pharmaceuticals (West Chester, PA)
- Director , Regulatory Affairs , Strategy - Innovative Medicine (West Chester, PA or Remote) Date: Apr 29, 2024 Location: West Chester, United States, ... people to make a difference with. **The opportunity** The Director , Global Regulatory Affairs , is...As a global or regional lead within a global regulatory team, develops/coordinates/implements regulatory strategy … more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- 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
- 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)
- …with respect to impact development programs. Additionally, this position interacts with Regulatory Affairs (RA) team members, cross-functional team members, FDA ... Experience in the pharmaceutical industry + 7 or More Years with direct regulatory affairs experience + Managerial experience preferred + Experience with ex-US… 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
- Mitsubishi Chemical Group (Jersey City, NJ)
- …on real-world evidence, and creating hope for all facing illness. The Senior Director , Commercial Regulatory Affairs , is responsible for the development ... and execution of the post-approval regulatory strategy , post-marketing commitments,post-marketing development and maintenance,...products in US and Canada. In addition, the Senior Director , Commercial Regulatory Affairs , in… more
- Gilead Sciences, Inc. (Foster City, CA)
- …exciting opportunity within our US Medical Affairs leadership team for a Senior Director , Medical Affairs Strategy within Liver Disease. **This role will ... Director USMA Liver Disease, the Senior (Sr.) Director Medical Affairs Strategy role...meetings. + Must be fully cognizant and adhere to regulatory and legal (Business Conduct) requirements for clinical trials… more
- Gilead Sciences, Inc. (Foster City, CA)
- …than 35 countries worldwide, with headquarters in Foster City, California. **Sr Director , CMC Regulatory Affairs -Small Molecules** **KEY RESPONSIBILITIES** ... The Sr Director , CMC Regulatory Affairs for Small Molecules is responsible...the projects they are responsible for have a cohesive regulatory strategy that is integrated into Pharmaceutical… more
- Gilead Sciences, Inc. (Foster City, CA)
- …the Medical Sr. Director , Strategy Lead of PAQ Virology. The Associate Director of Medical Affairs - PAQ Virology will support the US launch planning and ... diseases. We have an exciting opportunity within US Medical Affairs for an Associate Director in our...PBC therapeutic area. + Identify and develop patient access strategy and research opportunities for US payers and key… more
- Amgen (Washington, DC)
- …over 10 million patients worldwide. It's time for a career you can be proud of. ** Regulatory Affairs Senior Director - Global Regulatory Leader - ... this. Let's change the world. Amgen is seeking a Regulatory Affairs Senior Director supporting...Amgen's GRAAS organization + To independently develop a comprehensive regulatory strategy for one or more high… more
- Teva Pharmaceuticals (West Chester, PA)
- Senior Director Regulatory Affairs CMC (Biologic Products) Date: May 15, 2024 Location: West Chester, United States, Pennsylvania, 19380 Company: Teva ... to make a difference with. **The opportunity** The Sr. Director , Global Regulatory Affairs CMC...strategy and assessing the quality of documents for regulatory submissions to major market health authorities as well… more
- New York State Energy Research and Development Aut (Albany, NY)
- …residents to benefit equitably from energy efficiency and renewable energy. Job Overview The Director of Regulatory Affairs will report to the Vice President ... of Government and Regulatory Affairs and be responsible for building... team within NYSERDA. Working with the VP, the Director will lead cross-cutting and inter-agency policy advancement activities… more
- Boehringer Ingelheim (Ridgefield, CT)
- …approach and informs medical affairs efforts where applicable. The Director , Clinical Development Strategy Team Member collaborates cross functionally across ... reflect Boehringer Ingelheim's high regard for our employees. The Director , Clinical Development Strategy Team Member is...steps. + Collaborates very closely with the respective Medical Affairs Strategy team member counterparts to ensure… more
- Merck (North Wales, PA)
- **Job Description** The Director , Regulatory Affairs Liaison, is responsible for development and implementation of global regulatory strategy for ... the Worldwide Regulatory Agencies and/or subsidiaries with regard to global regulatory strategy /registration requirements for one or more of our Company's… more
- Teva Pharmaceuticals (West Chester, PA)
- Associate Director , Regulatory Affairs - Remote OR West Chester, PA Date: May 15, 2024 Location: West Chester, United States, Pennsylvania, 19380 Company: ... with. **How you'll spend your day** As the Associate Director , Regulatory Affairs you will...and regulatory leadership in defining the global regulatory strategy for biosimilar (BioS) projects. You… more
- BD (Becton, Dickinson and Company) (Covington, GA)
- **Job Description Summary** As Associate Director , Regulatory Affairs , you will be responsible for managing a team that develops and executes the strategy ... RA leadership team representative. + Responsible for the global regulatory strategy for UCC products + Leads...and regulation or guidance changes to Corporate Quality and Regulatory Affairs . International Regulatory … more
- Abbott (Abbott Park, IL)
- … data is maintained in electronic systems. + Depending on specific role, the Associate Director Regulatory Affairs may be involved in various regulatory ... colleagues serve people in more than 160 countries. **Associate Director of Regulatory Affairs ** **About...arguments, identify regulatory scientific data needs, solve regulatory issues, and define regulatory strategy… more
- Gilead Sciences, Inc. (Foster City, CA)
- …an exciting opportunity within our US Medical Affairs Liver team for a Director , Medical Affairs Strategy for Primary Biliary Cholangitis. **This role is ... based in Foster City, CA.** ** Director , US Medical Affairs (USMA)Liver - PBC**...care. + Ability to think strategically and translate that strategy into an actionable work plan. + Excellent written,… more
