- Takeda Pharmaceuticals (Boston, MA)
- …collaboration with Takeda teams and leadership through networks and enable CMC regulatory team's success in meeting goals/objectives on drug -device combination ... Factors + Authors, reviews, provides critical assessments and gives input on drug -device combination regulatory strategies in regulatory filings through… more
- Merck (Boston, MA)
- **Job Description** We are seeking a Director (Principal Scientist), Global Regulatory Affairs Liaison with a visionary, growth-oriented mindset that can help ... advance our pipeline and drive our strategic priorities. The Director , Principal Scientist | Regulatory Affairs Liaison...teams for meetings with FDA at any phase of drug development. Lead cross-functional efforts to prepare for advisory… more
- Takeda Pharmaceuticals (Columbus, OH)
- …the best of my knowledge. **Job Description** **About the role:** **Associate Director , Nonclinical Regulatory Writing and Submission Support,** **_Oncology and ... engage in meaningful work? Join us as an _Associate Director - Nonclinical Regulatory Writer_ _and Submission...team members (Clinical, Global Patient Safety, Program Management, Global Regulatory , Regulatory Operations, Drug Discovery… 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
- Regeneron Pharmaceuticals (Troy, NY)
- The Director of CMC Industry and Regulatory Intelligence is responsible for enabling chemistry manufacturing and controls (CMC) quality and compliance excellence ... standards for all CMC operations across Regeneron. As a Director of CMC Industry and Regulatory Intelligence,...industry trends, for relevance and impact to internal processes, drug development projects and/or regulatory strategies and… more
- West Pharmaceutical Services (Exton, PA)
- Director , Regulatory Affairs, Intelligence Requisition ID: 67704 Date: Oct 23, 2024 Location: Exton, Pennsylvania, US Department: Regulatory Affairs ... environment and planet through our sustainability efforts. **Job Summary:** + The Director , Regulatory Affairs, Intelligence is expected to perform with minimal… more
- Merck (Boston, MA)
- **Job Description** We are seeking a Senior Director (Sr. Principal Scientist) Global Regulatory Affairs Liaison with a visionary, growth-oriented mindset that ... external to GRACS. **Key Functions** + Reports to Executive Director or Associate Vice President, General Medicine + Works...marketed products throughout the entire life cycle of the drug + Provide leadership to the Global 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
- Takeda Pharmaceuticals (Lexington, MA)
- …true to the best of my knowledge. **Job Description** Join Takeda as an Associate Director , US Advertising & Promotion Regulatory Review out of our Lexington, MA ... guidance, and enforcement trends governing the promotion of prescription drug and biologic products. + Provide regulatory ...prescription drug and biologic products. + Provide regulatory strategic oversight for at least one (1) complex… more
- J&J Family of Companies (Columbus, OH)
- Director , Regulatory Medical Writing (1 of 4) - 2406211847W **Description** Johnson & Johnson is currently seeking a Director , Regulatory Medical ... potential. At Johnson & Johnson, we all belong. The Director , Regulatory Medical Writing (RegMW) is a...applications is required. + Knowledge of the clinical end-to-end drug development process is required. + Strong content awareness… 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
- 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)
- Director , Therapy Area Head, Global Regulatory Medical Writing (USA, Remote) Date: Oct 19, 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
- 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
- Merck (Columbus, OH)
- **Job Description** The Executive Director , Device Quality & Regulatory will play a pivotal leadership role within the organization, overseeing the quality ... assurance and regulatory CMC for complex medical devices, including auto-injectors and...for complex medical devices, including auto-injectors and other innovative drug delivery systems associated with combination products. This role… 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