- Takeda Pharmaceuticals (Boston, MA)
- …possible in order to bring life-changing therapies to patients worldwide. Join Takeda as Director , Global Regulatory Labeling Strategy where you will be ... approval by Labeling Senior Management Cross-functional team ( Global Labeling Oversight Committee - GLOC) providing...+ Liaises with US Labeling Operations, EU Labeling Operations, Labeling Devices Lead… more
- Lilly (Indianapolis, IN)
- … Global Regulatory Team consisting of regional regulatory scientists, GRA-CMC, GRA- Devices , GRA-RD&E, and GRA- Global Labeling and Product Communications. ... a global regulatory strategy which supports product (including delivery device and relevant medical devices ) development, registration, and lifecycle… more
- Lilly (Indianapolis, IN)
- … Global Regulatory Team consisting of regional regulatory scientists, GRA-CMC, GRA- Devices , GRA-RD&E, and GRA- Global Labeling and Product Communications. ... a global regulatory strategy which supports product (including delivery device and relevant medical devices ) development, registration, and lifecycle… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Associate Director , Global Regulatory Affairs Advertising and Promotion **Location** : Cambridge, MA Morristown, NJ **About the Job** Are you ... of Prescription Drug Promotion (OPDP) and Advertising and Promotion Labeling Branch (APLB). We are an innovative global...and updating of standards and processes related to drug, device , and biologics US AdPromo regulations and guidances. +… more
- Candela Corporation (Marlborough, MA)
- ** Director , Global Regulatory Affairs** Requisition Number **2872** Location **US - Marlborough, MA** State/Territory **Massachusetts** **Company Overview:** ... Candela Corporation is a leading global aesthetic device company with a comprehensive...distributors in over 60 other countries. **General Summary** The Director , Global RA will be fully accountable… more
- Oura (San Francisco, CA)
- …decision-making and regulatory adherence across the organization. + Partner with the Sr. Director - Global Risk & Asset Protection on investigative matters ... and digital health compliance. + Strong understanding of FTC advertising regulations and global health product labeling laws. + Proven experience in developing… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …regulatory submission content (510(k), Technical Files, etc.) + Develop and implement global regulatory strategy for MMS Dispensing Medical Device and ... Summary** **Job Description** BD is one of the largest global medical technology companies in the world and is...self. Become a maker of _possible_ with us. The Director of Regulatory Affairs reports directly to the Senior… more
- Gilead Sciences, Inc. (Foster City, CA)
- …the Device Engineering, Primary Container, Process Development, Packaging, and Labeling functions, and work closely with Strategy & Operations, Human Factors, ... aspirations. Join Gilead and help create possible, together. **Job Description** The Director , New Product Planning & Drug Delivery Innovation, will serve an… more
- BD (Becton, Dickinson and Company) (Warwick, RI)
- **Job Description Summary** The Director Regulatory Affairs (RA) Position reports directly to the BD Interventional Segment's Surgery VP Regulatory Affairs. This ... platform. In addition to the platform leadership role, the Director will be responsible for developing and communicating RA...of possible** ! BD is one of the largest global medical technology companies in the world. _Advancing the… more
- Glenmark Pharmaceuticals Inc., USA (Elmwood Park, NJ)
- …Skills + Excellent communication skills including: verbal, reading and writing. + Use various labeling software tools such as TVT and/or Global Vision. Can be ... Associate Director , Regulatory Affairs Department: Regulatory Affairs Location: Elmwood...conversion to OTC or OTC Monograph direct including any labeling reviews and updates. + Ensure all manufacturing, packaging,… more
- Roche (Indianapolis, IN)
- …medical affairs, legal, and other business stakeholders. The Regulatory Compliance Director may contribute to global cross-functional or cross-chapter squads, ... every voice matters. **The Position** **The Opportunity** The Regulatory Compliance Director is a people leader role. Primary responsibilities include leading a… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …Description** **We are the makers of possible** BD is one of the largest global medical technology companies in the world. Advancing the world of health (TM) is ... that turn dreams into possibilities. We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an… more
- GRAIL (Menlo Park, CA)
- …North Carolina, and the United Kingdom. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies. For more information, ... position supports the US Regulatory team in preparing Investigational Device Exemptions (IDEs), IDE supplements, pre-submissions, Premarket Approvals (PMAs), annual… more
- AbbVie (Barceloneta, PR)
- …LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The ME&C Associate Director is a global program management expert responsible for ... efficiency and cost avoidance/reduction. Understand and integrate changes in the global landscape for device and combination product industrialization, … more
- J&J Family of Companies (Titusville, NJ)
- …for humanity. Learn more at https://www.jnj.com/. **POSITION SUMMARY:** The Senior Director , Clinical Leader (CL) is responsible for development and execution of ... study reports and for the preparation and approval of essential documents for global regulatory filings. The CL will manage direct reports who are project… more
- Sanofi Group (Cambridge, MA)
- …with FDA are established and maintained. + Provides input into the global organization for labeling strategies of marketed drugs. Demonstrates significant ... **Job Title:** Director , US Regulatory Affairs - Advertising and Promotion...helping our teams accelerate progress. We are an innovative global healthcare company with one purpose: to chase the… more
- Abbott (Alameda, CA)
- Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of ... healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines. Our 114,000 colleagues serve people in… more
- Abbott (San Diego, CA)
- …role is part of the RA New Product Introduction (NPI) team, reporting to the Director of Global NPI and US Regulatory Affairs. We're empowering smarter medical ... Abbott is a global healthcare leader that helps people live more...healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines. Our 114,000 colleagues… more
- Edwards Lifesciences (Naperville, IL)
- **Sr. Director , Global Professional Education, Training - IHFM** Many structural heart patients suffer from heart failure with limited options. Our Implantable ... be part of our inspiring journey. **Position Summary:** Manage team and related global professional and commercial education activities as it relates to new product… more
- Takeda Pharmaceuticals (Boston, MA)
- …well as other labeling documents. + Demonstrate knowledge of local and global health authority requirements. + Support GPSE in the maintenance of a highly ... knowledge. **Job Description** **Objective:** **Principal responsibilities include:** + Serves as Global Safety Lead (GSL) and the Company-wide patient safety expert… more