- Beth Israel Lahey Health (Woburn, MA)
- … medical staff services in support of credentialing, privileging, governance, regulatory readiness, and professional practice evaluation. The Director oversees ... such as committee meeting minutes, reports, and committee actions. **Compliance, Quality , and Regulatory Readiness:** + Monitor and maintain compliance… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Director , Global Regulatory Affairs - Global Labeling Strategy **Location** : Morristown, NJ or Cambridge, MA (Hybrid) **About the Job** Are you ... Your skills could be critical in helping our teams accelerate progress. The Director , Global Regulatory Affairs - Global Labeling Strategy is responsible for… more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as Director , Global Regulatory Labeling Strategy where you will be responsible for ... regulatory nuances and requirements. + Understanding of scientific principles and regulatory / quality systems relevant to drug development. + Ability to… more
- Rhythm Pharmaceuticals (Boston, MA)
- …across functions, and ensuring quality , accuracy, and adherence to regulatory guidelines. Additionally, the Associate Director supports the preparation and ... and our tenacity to overcome barriers, together. Opportunity Overview The Associate Director (AD) of Regulatory Operations is responsible for assisting the… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- …documents focused on strategic and scientific content. + Build, lead and mentor the regulatory team and provide project teams with the strategic regulatory ... and internal stakeholders. A typical day as an Executive Director might look like: + Responsible for the strategic...investigational and commercial products + Directs and oversees the Regulatory CMC function in preparing high- quality CMC… more
- Takeda Pharmaceuticals (Lexington, MA)
- …therapies and other unique modalities + Represents, contributes and influences Regulatory , Pharmaceutical Development, and Commercial project teams throughout ... a GRA CMC member, ensures and / or enhances regulatory compliance. + Ensures project team colleagues,...regulatory individuals to ensure timely delivery of high quality of regulatory dossiers and strategies according… more
- Takeda Pharmaceuticals (Boston, MA)
- …**Objective / Purpose:** The Head of Design & Delivery, Development & Regulatory will lead the global technical product strategy across Takeda's development ... technology portfolio, encompassing Clinical Development, Regulatory Affairs, and Pharmacovigilance domains. This role is accountable...CFR Part 11, ICH, EMA, FDA, PMDA) and Takeda's quality and risk management standards. + Work closely with… more
- Takeda Pharmaceuticals (Boston, MA)
- …planning and execution. + Ensures a system within PDT RA for driving regulatory quality compliance and efficiency across the organization. + Accountable for ... or related experience is required. Scientific or closely related field preferred. + Project management qualification. + 7-10 years of regulatory experience in… more
- Fresenius Medical Center (Waltham, MA)
- …high- quality pharmaceutical products. **PRINCIPAL DUTIES AND RESPONSIBILITIES:** + ** Regulatory Strategy Leadership:** + Lead the development of global ... agencies, and industry groups. + Provide leadership in managing global regulatory submissions, ensuring efficient and high- quality execution. + **Market Access… more
- Sanofi Group (Waltham, MA)
- **Job Title:** Statistical Project Leader, Deputy Director , Global Biostatistics Sciences **Location** : Waltham, MA **About the Job** Are you ready to shape the ... critical in helping our teams accelerate progress. The Statistical Project Leader serves as the lead on small to...clinical team meetings and may attend external meetings with regulatory agencies and key opinion leaders. We are an… more