- Astellas (Westborough, MA)
- …Senior CMC Regulatory Affairs Manager, Cell/Gene Therapy Manager CMC Regulatory Affairs , Gene Therapy Associate Director CMC Regulatory ... business with ethics and integrity, so that we can continue to change global health for the better. Explore these exciting opportunities located at our Westborough,… more
- Sanofi Group (Cambridge, MA)
- …the advertising and promotion of prescription drugs and biologics. Essential Functions + Represents Global Regulatory Affairs (US RA AdPromo) as a member of ... About the Role The Associate Director , US Regulatory Affairs ...Consults with senior management and provides input to the global organization as needed. + Contributes US RA AdPromo… more
- Sanofi Group (Cambridge, MA)
- …and Capabilities** + This individual is expected to competently and confidently represent Regulatory Affairs as a key member of cross-functional RC teams for ... The Associate Director RA serves as the regulatory lead on Review Committees (RCs). As the RC RA representative, work with brands on competitively positioning… more
- J&J Family of Companies (Boston, MA)
- Associate Director , Regulatory Affairs - 2406166277W **Description** Janssen Research & Development, LLC, a member of Johnson & Johnson's Family of ... Companies, is recruiting for an Associate Director , Regulatory Affairs . This position...exist. + Integrate multiple inputs from regional and functional Global Regulatory Team members to build coherent… more
- Bausch Health (South Boston, MA)
- …health care products. The Executive Director of Advertising & Promotion- Regulatory Affairs prescription drug products manages and, if required participates ... Bausch Health is a global company that develops, manufactures, and markets a...Regulatory Promotional reviews for prescription drugs who represent Regulatory Affairs on the promotional review committee… more
- Medtronic (Boston, MA)
- …you need to own your future success. Together, we can transform healthcare. The Senior Director of Regulatory Affairs will lead the Regulatory team ... technologies to market. It involves creating, managing and executing global regulatory strategies for new product development...be required. This role reports to the Vice President, Regulatory Affairs for the Surgical Operating Unit… more
- Bausch Health (Boston, MA)
- …and procedures to enhance efficiencies and compliance. + Works closely with the Regulatory Affairs labeling group regarding package insert changes to assess and ... Bausch Health is a global company that develops, manufactures, and markets a...and the ability to see business drivers outside of regulatory affairs + Working knowledge of the… more
- Randstad US (Cambridge, MA)
- associate director , external scientific engagement lead, global medical affairs oncology. + cambridge , massachusetts + posted 10 days ago **job details** ... and related tactics for prioritized external organizations and HCPs, aligned across Global Medical Affairs Oncology, Commercial, Patient Value, Policy & Access,… more
- ConvaTec (Lexington, MA)
- …analyses, and generation of publications. You will have close liaison with Clinical Affairs , Global Education, Regulatory , Quality, Marketing & Business ... to improve the lives we touch: Convatec is a global medical products and technologies company, focused on solutions...grow while honing your strategic thinking skills Our successful Director /Senior Manager Medical Affairs will be involved… more
- Philips (Cambridge, MA)
- … regulatory files and tracking databases as required. + Reporting to the Director of Regulatory Affairs - Coronary Vascular you will collaborate with ... The Principal Regulatory Affairs Specialist will play a...Coronary Vascular products are safe, reliable, and compliant with global regulatory standards through team leadership and… more
- Olympus Corporation of the Americas (Westborough, MA)
- …and our core values by staying **True to Life.** **Job Description** The Global Lead, Medical Affairs , GIET is a qualified gastrointestinal endoscopist that ... team members in Clinical Affairs , Operations Center of Excellence, Professional Affairs , Health Economics and Market Access, R&D, Regulatory , and Medical… more
- Takeda Pharmaceuticals (Boston, MA)
- …, Global Regulatory Project Management, GI 2 within our Global Regulatory Affairs organization, based remotely. **_OBJECTIVES/PURPOSE_** + Partners ... with the Global Regulatory Lead (GRL) on ...the pharmaceutical industry and drug development project management and regulatory affairs (eg, clinical development, the prescription… more
- Olympus Corporation of the Americas (Westborough, MA)
- … regulatory agencies regarding compliance issues. Directs the development of global regulatory communication processes to include responses to external audits ... by applicable federal, state or local law. Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Quality & Regulatory Affairs (QA/RA) more
- J&J Family of Companies (Boston, MA)
- Associate Director , Regulatory Program Manager (1 of 7)... Regulatory Leader (GRL) and partners across Global Regulatory Affairs as well as ... Johnson's Family of Companies, is recruiting for an **Associate Director , Regulatory Program Manager** . This position...of FDA/EMA procedures is required. + Demonstrated understanding of Global Regulatory Affairs processes is… more
- AbbVie (Boston, MA)
- …responses to health authority information requests. In partnership with the Global Regulatory Product Team (GRPT), the RSW Associate Director and his or her ... that perform similar activities to optimize writing processes within AbbVie and Regulatory Affairs . Build strategic partnerships and develop a strong knowledge… more
- Pfizer (Cambridge, MA)
- …(eg pre-clinical, clinical operations, clinical systems, finance, R&D or procurement, medical affairs , regulatory affairs ) + Extensive background in clinical ... **ROLE SUMMARY** + The Vendor Strategy Category Director will serve as the single point of...assessment, onboarding, and monitor performance of vendors in Oncology Regulatory and Medical Affairs Strategy + Serve… more
- Takeda Pharmaceuticals (Boston, MA)
- … Project Management and Strategic Planning - GI2 TAU within our Global Regulatory Affairs organization, based remotely. **_OBJECTIVES/PURPOSE_** + ... implementing process changes through proactive engagements with cross functional team members, Global Regulatory Affairs TAU colleagues and Global … more
- Cardinal Health (Boston, MA)
- …of capacities, including: + Global Regulatory Strategy Development + Global Regulatory Affairs + Chemistry Manufacturing and Controls Development + ... brand for post-approval success in obtaining the greatest market share possible. The Director , Business Development with Cardinal Health Regulatory Sciences is a… more
- Orchard Therapeutics (Boston, MA)
- … lead on assigned early-stage program(s) o Work in close partnership with the Global Regulatory Lead(s) to provide necessary regulatory inputs to the ... in line with corporate goals, in partnership with the Global Regulatory Lead(s) and the program ...regulatory strategies for development programs in industry-related US Regulatory Affairs - Expert knowledge and understanding… more
- Sanofi Group (Cambridge, MA)
- …pharmaceutical/biotechnology industry experience, including at least 4 years of relevant Regulatory Affairs experience (regionally and/or global ) especially ... + Leads the US regulatory activities. + As a key member of the Global Regulatory Team (GRT), and strategic partner to the Global Regulatory Lead… more