- Medtronic (Boston, MA)
- …need to own your future success. Together, we can transform healthcare. The Senior Director of Regulatory Affairs will lead the Regulatory team for ... be required. This role reports to the Vice President, Regulatory Affairs for the Surgical Operating Unit... staff and coach to ensure continuing development of regulatory skills + Keep Senior Management informed… more
- Blue Cross Blue Shield of Massachusetts (Boston, MA)
- Ready to help us transform healthcare? Bring your true colors to blue. The Senior Director , Federal Government Affairs will manage BCBSMA activities to ... to the Vice President, State and Federal Government and Regulatory Affairs , and senior leaders...in an integrated and highly effective manner. + The Senior Director , Federal Government Affairs … more
- Sanofi Group (Cambridge, MA)
- About the Role The Associate Director , US Regulatory Affairs (RA) serves as the regulatory lead on relative Review Committees (RCs), for products in the ... and promotion of prescription drugs and biologics. Essential Functions + Represents Global Regulatory Affairs (US RA AdPromo) as a member of cross-functional… more
- ConvaTec (Lexington, MA)
- …to constantly learn and grow while honing your strategic thinking skills Our successful Director / Senior Manager Medical Affairs will be involved in all ... and generation of publications. You will have close liaison with Clinical Affairs , Global Education, Regulatory , Quality, Marketing & Business Development and… more
- Philips (Cambridge, MA)
- …internal or external quality system audits. + Reporting to the Director of Regulatory Affairs , the Senior RA Specialist will collaborate with global team ... Recommends strategies for earliest possible approvals of clinical trials applications. + Regulatory Affairs representative for the CT/AMI Systems and assists… more
- Takeda Pharmaceuticals (Lexington, MA)
- …process improvements to address potential issues. Accountabilities: + Collaborate with Regulatory Affairs , Medical, Legal, Commercial, and Compliance, execute ... the best of my knowledge. **Job Description** The Associate Director , US Medical Ad/Promo Regulatory serves as... regulatory requirements. + Understand broad concepts within Regulatory Affairs and possible effects across the… more
- State of Massachusetts (Boston, MA)
- …**Office of Consumer Affairs and Business Regulation* **Title:** * Senior Director of Programs* **Location:** *Massachusetts-Boston - 501 Boylston ... Call Registry; and Data Breach Notification ("the Programs"). The Senior Director of Programs ("SDP") reports to...to the Programs, and assists the Constituent and Legislative Affairs Director in developing responses to legislators… more
- Sanofi Group (Cambridge, MA)
- … regulatory policy efforts. Reporting through Region North America within Global Regulatory Affairs (GRA), the candidate will work collaboratively with both ... to have a positive impact on the environment advise internal stakeholders on evolving regulatory policy issues, and more! The Director will be a strong subject… more
- Takeda Pharmaceuticals (Lexington, MA)
- …to address potential issues. **Accountabilities:** . Collaborate with colleagues in Regulatory Affairs , Medical, Legal, Commercial, and Compliance organizations ... **Job Description** **About the role:** Join Takeda as a Senior Manager, US Medical Ad/Promo Regulatory Review,... regulatory requirements. . Understand broad concepts within Regulatory Affairs and potential effects across the… more
- Takeda Pharmaceuticals (Lexington, MA)
- …potential issues. **Position Accountabilities:** * Collaborate with colleagues in Regulatory Affairs , Medical, Legal, Commercial, and Compliance organizations ... **Job Description** **About the role:** Join Takeda as a Senior Manager, US Medical Ad/Promo Regulatory Review... regulatory requirements. * Understand broad concepts within Regulatory Affairs and potential effects across the… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …MDMP interacts and partners with marketed products R&D function leads ( regulatory affairs , pharmacovigilance, global development operations and project ... integrated partnership(s) with R&D functional leads on assigned R&D MPT ( regulatory affairs , pharmacovigilance, global development operations). + Collaborate… more
- Takeda Pharmaceuticals (Boston, MA)
- …the Regulatory Affairs CMC team, you will report to the Executive Director and Head, CMC Regulatory Affairs - Pharmaceuticals. **How you will ... order to bring life-changing therapies to patients worldwide. Join Takeda as a Senior Director , GRA Pharmaceuticals- Small Molecule where you will establish… more
- Merck (Boston, MA)
- …placement, monitoring, analysis, regulatory reporting, and publication. **Specifically, the Senior Director may be responsible for:** + Providing scientific ... medicines span all phases of clinical development (pre-clinical to post-licensure). The Senior Director will manage the entire cycle of clinical development,… more
- Sanofi Group (Cambridge, MA)
- …pharmaceutical/biotechnology industry experience, including at least 4 years of relevant Regulatory Affairs experience (regionally and/or global) especially in ... **Main responsibilities:** + Leads the US regulatory activities. + As a key member of...regions / GRA-CMC /GRA-Devices to communicate the outcome to senior management as needed + May lead Health Authority… more
- Sanofi Group (Cambridge, MA)
- …pharmaceutical/biotechnology industry experience, including at least 4 years of relevant Regulatory Affairs experience (regionally and/or global) especially in ... team** The team is involved in developing and executing regulatory strategies for Tzield in life cycle development stages...regions / GRA-CMC /GRA-Devices to communicate the outcome to senior management as needed + May lead Health Authority… more
- Olympus Corporation of the Americas (Westborough, MA)
- …by applicable federal, state or local law. Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Quality & Regulatory Affairs (QA/RA) ... staying **True to Life.** **Job Description** Leads and directs regulatory compliance communications to ensure compliance of the Global...areas of compliance risk and present these risks to senior leadership at Olympus in a clear and concise… more
- Harvard University (Cambridge, MA)
- …Manager Department Office Location:USA - MA - Cambridge Business Title: Senior Director of Compliance for Strategic Research InitiativesSub-Unit:Office ... + Thorough understanding of a broad spectrum of the regulatory and policy requirements related to research administration and...the Office of the Vice Provost for Research, the Senior Director of Compliance for Strategic Research… more
- Takeda Pharmaceuticals (Boston, MA)
- …opportunities for either partnering and/or investment. + In collaboration with Global Regulatory Affairs (GRA), monitor and communication with Takeda Oncology ... Identify, monitor and review near-term (within 3 years of regulatory approval) oncology partnering opportunities + Lead / co-lead...with Global Product / Project Teams and Global Medical Affairs (GMA), assist in the development of Life Cycle… more
- Fresenius Medical Center (Lexington, MA)
- Senior Director , Medical Delivery Excellence, Fresenius USA Marketing, Inc., a Fresenius Medical Care NA company, Lexington, Massachusetts Responsible for ... Verticals (Product Owners, Tech/Ops, Production, Risk Management, Product Center Management, Regulatory Affairs ); + Oversee the establishment and execution of… more
- Sanofi Group (Cambridge, MA)
- …clinical development teams to ensure alignment with clinical trial objectives, and regulatory affairs to navigate pathways to support clinical evaluation and ... successful transition to late-stage development teams and commercialization. Additionally, the Early-Stage Portfolio Lead is responsible for concept development of innovative medical device technologies, from ideation to proof of concept, in order to de-risk… more