- Merck & Co. (Boston, MA)
- …(including discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs , and global clinical trials operations)Provide ... Translational Medicine Operations, Translational Medicine-EU, Drug Metabolism/Modeling & Simulation, Regulatory Affairs , and late-stage Clinical Research throughout… more
- Syner-G BioPharma Group (Boston, MA)
- …systems, and energy management.Collaborate with internal stakeholders including EHS, IT, and Regulatory Affairs to support compliance and operational ... and hands-on expertise to streamline operations, enhance quality systems, and ensure regulatory compliance , empowering our clients to navigate complexity and… more
- Carrier (Beverly, MA)
- …to innovation, sustainability, and global impact. **About this role** As the ** Regulatory Affairs & Compliance Lead ** at **Sensitech** , you will be the ... this strategic individual contributor role, the ** Regulatory Affairs & Compliance Lead ** collaborates...role, the ** Regulatory Affairs & Compliance Lead ** collaborates cross-functionally with Product Development,… more
- Sanofi Group (Cambridge, MA)
- **Job title** : Global Regulatory Affairs Device Lead (Associate Director) **Location** : Morristown, NJ or Cambridge, MA or Framingham, MA **About the Job** ... critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device team is a...proposed product changes + May serve as a regional/local regulatory lead and point of contact with… more
- Sanofi Group (Framingham, MA)
- **Job Title:** Global Regulatory Affairs CMC lead **Location:** Framingham, MA, Morristown, NJ **About the Job** Are you ready to shape the future of ... strategic negotiations with health authorities worldwide. Within Sanofi's Global Regulatory Affairs (GRA) CMC organization, the CMC Lead role offers the… more
- Evident Scientific (Needham, MA)
- …every day. **Let's inspire healthier lives, together.** This role bridges Clinical Affairs and US Regulatory Compliance , leading end-to-end clinical ... compliance activities. Reporting to the Global Director of Regulatory Affairs - Clinical Business, the incumbent... Affairs (US Focus)** + Act as US regulatory lead for clinical and medical device… more
- Olympus Corporation of the Americas (Westborough, MA)
- …OSTA Core Regulatory Affairs Team and provides world-class regulatory strategies for digital health solutions, ensuring compliance with applicable global ... Senior Manager to plan and direct the OSTA Core Regulatory Affairs Team activities including but not...with functions across the business. + Deep experience in regulatory compliance for digital health software not… more
- Sumitomo Pharma (Boston, MA)
- …dynamic, highly motivated, and experienced leader for the position of **Vice President, Regulatory Affairs Oncology** . The candidate must be deeply experienced ... to VP Clin Dev and CMO + Manage Commercial Regulatory Affairs function and serve as an...advertising and promotion of prescription drugs + Guide and/or lead regulatory agency interactions, including communications and… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …therapies to patients worldwide. The Associate Director, Global Regulatory Affairs Advertising and Promotion (GRA A&P) Review Lead is accountable ... you will contribute:** + As our Associate Director, Global Regulatory Affairs Advertising and Promotion lead...promotion processes with a focus on patient safety and compliance . Additional Skills: + Leadership Skills can lead… more
- Sumitomo Pharma (Boston, MA)
- …highly motivated, and experienced individual for the position of **Associate Director, Regulatory Affairs (Oncology).** The Associate Director is part of the ... Global Regulatory Affairs (GRA) team based in the...mentoring. **Job Duties and Responsibilities** + As a Regional Regulatory Lead , manage regional (United States, European… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- **Job Summary** The Chemistry, Manufacturing and Controls (CMC) Global Regulatory Affairs (GRA) professional is responsible for developing and executing global ... and perspective to the cross-functional team. Serve as CMC regulatory lead on global project teams (Pharmaceutical...other local and/or global functional units [OPC CMC Global Regulatory Affairs , Global Regulatory Strategy,… more
- Takeda Pharmaceuticals (Boston, MA)
- …the global regulatory strategy is updated and executed, ensuring global regulatory compliance and/or oversees direct reports or junior staff responsible. + ... influence in or leads departmental and cross-functional task-forces and initiatives. + Lead regulatory reviewer in due diligence for licensing opportunities. +… more
- Bristol Myers Squibb (Cambridge, MA)
- …influence. Proven ability to lead teams in making timely, high-quality regulatory decisions that balance innovation, compliance , and enterprise impact. + ... . **Position Summary** The Director of Early Precision Medicine Regulatory Affairs leads global regulatory ...and enabling timely, compliant submissions + Serve as the regulatory lead on the Translational Medicine CLIA… more
- ThermoFisher Scientific (Waltham, MA)
- … bodies. + Provide regulatory direction to product development teams. + Lead all aspects of regulatory compliance of advertising and promotional ... for cancer. **Discover Impactful Work** As a Sr. Manager, Regulatory Affairs , you will play a crucial...in the area of cell and gene therapy. + Lead maintenance and improvements to regulatory tools,… more
- Parexel (Boston, MA)
- …* Work on impactful global programs that directly support patient safety and regulatory compliance . * Collaborate with a diverse, international team across ... Foundational (US, EU, CH, DE, AU) and non-US/Central EU markets, ensuring compliance with global regulatory requirements and supporting cross-functional teams in… more
- Olympus Corporation of the Americas (Westborough, MA)
- …about Life at Olympus (https://www.olympusamerica.com/careers) . **Job Description** The Global Lead Medical Affairs - Gastroenterology (GLMAG) is a ... proficient in endoscopy with deep clinical practice knowledge, medical affairs industry experience, and/or health leadership competencies and management… more
- Takeda Pharmaceuticals (Boston, MA)
- …to data analytics and publication planning, including ideas for sub-analyses + ** Compliance and Regulatory :** Excellent understanding of regulatory , ... deliver your best. As part of the Global Medical Affairs Oncology team, you will report to the Scientific...team, you will report to the Scientific Communications Group Lead , Hematology. As a subject matter expert on scientific… more
- Chiesi (Boston, MA)
- …challenge the status quo for the better. Who we are looking for Purpose The Lead role reports to the Senior Director of Global Medical Affairs HIDO and ... is part of the Global Medical Affairs team. This position supports the development and implementation...matter expert within the therapeutic area. Main Responsibilities + Lead medical strategy and tactics in the US under… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …setting + Expertise in navigating regulatory frameworks and ensuring compliance within medical affairs function + Excellent communication and interpersonal ... with Otsuka's vision, direction, and growth strategy. The Executive Director, Medical Affairs Strategy, Excellence & Operations will lead five critical teams:… more
- Commonwealth Care Alliance (Boston, MA)
- 011110 CCA-Public Affairs **Position Summary:** The Director of State Government Affairs ("Director") sits within The Government Affairs team and reports to ... the Vice President of Government Affairs /CareSource. This position also supports the CCA Plan President. In collaboration with the VP, Government Affairs ,… more
