- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub ... Interactions: Leads US FDA/EU EMA interactions with support from higher-level manager . Regulatory Knowledge: Demonstrates expert knowledge of US/EU regulatory… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …The Regulatory Process Manager will be a key member of the Global Regulatory Affairs (GRA) Process Excellence & Analytics function, responsible for ... purpose and compliant with relevant regulations. This role will work with Global Regulatory Affairs and cross-functional teams (eg, Quality, CSPV, Clinical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …CSPV and external functions including Clinical Development, Research Development, Regulatory Affairs .Facilitate operational meetings with CROs, License Partners, ... for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Merck & Co. (North Wales, PA)
- …BARDS and will work collaboratively with other leaders in Clinical Development and Global Regulatory Affairs .--The AVP provides leadership and direction ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… more
- Hologic (Marlborough, MA)
- Manager , Global Regulatory Affairs Marlborough, MA, United States The Manager , Global Regulatory Affairs will support leadership, ... matrixed, global organization. Builds and maintains relationships within the Regulatory Affairs functional areas, Operations, Quality, and Research &… more
- Otsuka America Pharmaceutical Inc. (Bismarck, ND)
- **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed ... activities for all assigned projects in alignment with the Global Regulatory Lead. Translates complex pertinent ...experience or Master's degree with 2 years' experience in regulatory affairs or related areas (eg, clinical… more
- Teva Pharmaceuticals (West Chester, PA)
- … Regulatory Innovative Medicine Dossier Project Manager , a key member of Global Regulatory Affairs , will be responsible to develop and manage detailed ... Director, Regulatory Affairs - Dossier Project Manager Date:...to Global Regulatory Lead and Global Regulatory Affairs , with matrixed… more
- Boehringer Ingelheim (St. Joseph, MO)
- **Description** Manager The Manager , Regulatory Affairs (RA) Pharma Safety & Efficacy will represent the US regulatory safety and efficacy function ... in global development projects and provide regulatory strategy for assigned projects that leads to a...their assigned projects. This role is responsible for linking regulatory affairs information to internal and external… more
- Regeneron Pharmaceuticals (Sleepy Hollow, NY)
- …the Regulatory Affairs , Advertising and Promotion Director. The Senior Manager Regulatory Affairs , Advertising and Promotion will oversee therapeutic ... The Senior Manager position within the Regulatory Affairs department requires the ability...typical day might include:** + Management of US and Global (if applicable) regulatory activities associated with… more
- Abbott (Alameda, CA)
- …work for diversity, working mothers, female executives, and scientists. **The Opportunity** This ** Regulatory Affairs Manager - APAC** position will work ... their glucose levels with our new sensing technology. This ** Regulatory Affairs Manager - APAC**...Care product portfolio in the APAC region, creating robust global regulatory strategies, working with cross-functional teams… more
- Stryker (Shirley, MA)
- …Weston, FL with some workplace flexibility. As the ** Manager , Regulatory Affairs ** , you will lead and coordinate global regulatory activities ... We are currently seeking a ** Manager , Regulatory Affairs ** to...locations and time zones, cultures, and languages to support global sales growth. You will devote a significant portion… more
- AbbVie (Waltham, MA)
- …YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Senior Manager Regulatory Affairs , Chemistry, Manufacturing and Controls ... regulatory affairs on teams such as the product development, Global Regulatory Product Teams, and Operations brand teams for assigned projects;… more
- Bausch Health (Bothell, WA)
- …creates itwhere your skills and values drive our collective progress and impact. The Manager , Regulatory Affairs will be responsible for: + Responsible for ... CE Marking, global product registrations, and clinical evaluations/studies + Regulatory affairs professionals responsible to complete 510(K), Health Canada,… more
- Stryker (Weston, FL)
- …FL with some workplace flexibility. As the **Senior Manager , Regulatory Affairs ** , you will lead and coordinate global regulatory activities ... We are currently seeking a **Senior Manager , Regulatory Affairs ** to...global medical device regulations including direct experience with regulatory submissions associated with US and EU Class II/III… more
- Abbott (Alameda, CA)
- …diversity, working mothers, female executives, and scientists. **The Opportunity** This S **enior Regulatory Affairs Manager - APAC** position will work ... glucose levels with our new sensing technology. This **Senior Regulatory Affairs Manager - APAC**...Care product portfolio in the APAC region, creating robust global regulatory strategies, working with cross-functional teams… more
- Olympus Corporation of the Americas (Westborough, MA)
- …more about Life at Olympus (https://www.olympusamerica.com/careers) . **Job Description** Assist the Manager , Regulatory Affairs in obtaining approval to ... for registration of Olympus products in the EU. + Interface with International Regulatory Affairs Team to support preparation of dossiers for registration for… more
- Abbott (St. Paul, MN)
- …catheters and software, vessel closure devices and peripheral stents. **The Opportunity** This ** Regulatory Affairs Project Manager ** position is an onsite ... Division. As an individual contributor, the function of a Regulatory Affairs Project Manager is...and EU) for new, complex products. + Work with Regulatory leadership to prepare global regulatory… more
- Cordis (FL)
- …lives. **Responsibilities** Job Summary: We are seeking a highly strategic and hands-on **Senior Manager , Global Medical Affairs ** to serve as a foundational ... team member in building and executing the medical affairs strategy across key global markets. This...as the medical expert in cross-functional teams including R&D, Regulatory , Commercial, and Market Access. 10. Provide strategic and… more
- Abbott (Sylmar, CA)
- …of device and Cardiac Rythm Management solutions The Opportunity - We are seeking a Regulatory Affairs Project Manager to join our Cardiac Rythm Management ... Abbott is a global healthcare leader that helps people live more...CA. As an individual contributor, the function of a Regulatory Affairs Project Manager is… more
- GE Vernova (Wilmington, NC)
- **Job Description Summary** The US Licensing Manager , Regulatory Affairs , will lead a licensing team and manage the completion of various regulatory work ... licensing, customer plant support on GE Hitachi (GEH) / Global Nuclear Fuels (GNF) nuclear methods, and working with...projects. **Job Description** **Essential Responsibilities:** As the US Licensing Manager , Regulatory Affairs , you will:… more
