- Lilly (Indianapolis, IN)
- …to evolve how Lilly and LRL operates. The **Senior Director /Executive Director ** is responsible for managing all Regulatory activities (strategy and ... focus on US, UK, EU, and Canada. The Senior Director /Executive Director works with a multidisciplinary team...gap analysis and recommendations, advise on expedited pathways, orphan drug designation, and other regulatory advice meetings,… more
- Boehringer Ingelheim (Ridgefield, CT)
- …impact on patients' lives? Boehringer Ingelheim is seeking a dedicated and innovative Director /Senior Associate Director , Global Regulatory Affairs CMC for ... to the continuous improvement of processes and standards within Regulatory Affairs. If you have a strong background in...Ingelheim's high regard for our employees. The GRL CMC Director or Senior Associate Director has responsibility… more
- HCA Healthcare (Nashville, TN)
- …and integrity. We care like family! Jump-start your career as a Group Director Regulatory and Safety today with HCA Healthcare. **Benefits** HCA Healthcare, ... cost or for a low copay. Plans include prescription drug and behavioral health coverage as well as free...by location._** Come join our team as a Group Director Regulatory and Safety. We care for… more
- HCA Healthcare (Nashville, TN)
- …**Introduction** Do you want to join an organization that invests in you as a(an) Director Regulatory and Accreditation? At Work from Home, you come first. HCA ... cost or for a low copay. Plans include prescription drug and behavioral health coverage as well as free...make a difference. We are looking for a dedicated Director Regulatory and Accreditation like you to… more
- Ascendis Pharma (Princeton, NJ)
- …the promotion of prescription drug and biologic products. The Associate Director Regulatory Affairs, Advertising and Promotion is responsible for providing ... as one team to achieve extraordinary results. The Associate Director Regulatory Affairs, Advertising and Promotion will...have a minimum of 8 years of experience in drug , biologic and/or combination products in Regulatory … more
- HCA Healthcare (Nashville, TN)
- …Do you want to join an organization that invests in you as a Director Regulatory Education Surgical Services? At HealthTrust, you come first. HCA Healthcare ... cost or for a low copay. Plans include prescription drug and behavioral health coverage as well as free...make a difference. We are looking for a dedicated Director Regulatory Education Surgical Services like you… more
- Takeda Pharmaceuticals (Lexington, MA)
- …is true to the best of my knowledge. **Job Description** **Associate Director , US Advertising & Promotion Regulatory Review** **Takeda Pharmaceutical** ... PA** **About the role:** Join Takeda as an Associate Director , US Advertising & Promotion Regulatory Review...guidance, and enforcement trends governing the promotion of prescription drug and biologic products. + Provide regulatory … more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …on real-world evidence, and creating hope for all facing illness. The Director , Regulatory Affairs (Early Development) provides strategic global regulatory ... biologics/vaccines, and in the rare disease space. In this role, the Director defines and implements regulatory strategies; works with cross-functional project… more
- Amgen (Washington, DC)
- …team. Join us and transform the lives of patients while transforming your career. ** Regulatory Affairs Director - Global Regulatory Lead** **What you will ... do** Let's do this. Let's change the world. Amgen is seeking a Regulatory Affairs Director supporting products in Obesity Therapeutic Area. Global Regulatory … more
- Amgen (Washington, DC)
- …10 million patients worldwide. It's time for a career you can be proud of. ** Regulatory Affairs Director - Global Regulatory Leader - Oncology** **Live** ... you will do** Let's do this. Let's change the world. Amgen is seeking a Regulatory Affairs Director supporting products in the Oncology Therapeutic Area. Global … more
- AbbVie (Irvine, CA)
- …in which AbbVie systematically defines quality objectives, both strategic and applicable regulatory requirements. Director , Safety, Regulatory and Medical ... Quality Standards is responsible for the management of a RDQA global Safety, Regulatory Affairs (RA) and Medical Affairs (MA) QA team which provides independent… more
- Takeda Pharmaceuticals (Boston, MA)
- …order to bring life-changing therapies to patients worldwide. Join Takeda as a Senior Director , Global Regulatory Lead, GI & Inflammation where you will define, ... regional counterparts. **How you will contribute:** + The Senior Director will be responsible for complex or highly complex...+ Experience in reviewing, authoring, or managing components of regulatory submissions. + Expert knowledge of drug … 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, develop ... experience. + Preferred experience in reviewing, authoring, or managing components of regulatory submissions. + Solid working knowledge of drug development… more
- Teva Pharmaceuticals (Parsippany, NJ)
- Director , Therapy Area Head, Global Regulatory Medical Writing (USA, Remote) Date: Nov 17, 2024 Location: Parsippany, United States, New Jersey, 07005 Company: ... health and enable people to live better, healthier lives. **The opportunity** As a ** Director , in Global Regulatory Medical Writing (GRMW)** , you will primarily… more
- Ascendis Pharma (Palo Alto, CA)
- …dynamic workplace for employees to grow and develop their skills. The Associate Director , Regulatory Affairs will be responsible for developing and implementing ... drug -device combination products preferred. + Experience in filing regulatory dossiers including CTAs, IMPDs, INDs required; experience with marketing… more
- Takeda Pharmaceuticals (Lexington, MA)
- …leadership experience (3+ years) required. + Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and ... post-market support. + Proven ability to understand and communicate regulatory strategy to drug development, registration, and post-market support teams. + Base … more
- Teva Pharmaceuticals (Parsippany, NJ)
- Sr Director , Global Regulatory Medical Writing & Data Transparency Date: Oct 31, 2024 Location: Parsippany, United States, New Jersey, 07054 Company: Teva ... to make a difference with. **The opportunity** The Senior Director in Global Regulatory Medical Writing &...clinical research documentation, which adheres to departmental standards and regulatory guidelines in support of drug development,… more
- AbbVie (South San Francisco, CA)
- …technologies to discover and develop novel cancer treatments. We are currently seeking a Regulatory Affairs Director to join our growing regulatory team. In ... this role you would be the Global Regulatory Lead where you will develop and implement...+ Demonstrated understanding of regulations and guidelines governing oncology drug development and ability to strategically apply to overall… more
- BeiGene (San Mateo, CA)
- The Executive Director , Global Regulatory Portfolio Lead will be responsible for developing, implementing, and advising on global regulatory strategies for ... authorities as needed for all aspects pertaining to drug development including resolution of key regulatory ...to drug development including resolution of key regulatory issues and to expedite approvals of product and… more
- BeiGene (San Mateo, CA)
- …to negotiate with the US FDA as needed for all aspects pertaining to drug development including resolution of key regulatory issues and to expedite approvals ... **General** **Description** _:_ The Executive Director , Hematology North America Lead will be responsible...stakeholders. This individual will manage a minimum of 3 regulatory NA leaders (each who manage a group of… more