- Merck & Co. (Boston, MA)
- …regulatory , analytical, and epidemiological disciplines to ensure cohesive program execution and optimized product value throughout its lifecycle.Responsibilities ... and pipeline products to produce safe, effective, innovative medicine.The Clinical Director is responsible for protocol development and medical/ scientific oversight… more
- Pfizer (Cambridge, MA)
- The Director , Regulatory Program Management & Submission Strategy (RPMSS) provides comprehensive program management , ensuring alignment and ... deliverables. The Director , RPMSS serves as the regulatory program operational leader, ensuring all cross-functional...Advanced degree (PhD, PharmD, MBA) desirable. + Mastery of program management skills and significant expertise in… more
- Takeda Pharmaceuticals (Boston, MA)
- …that will inspire you and empower you to shine? Join us as an Associate Director , Global Regulatory Project Management and Strategic Planning - Oncology TAU ... leadership, oversight, direction and planning. + Directly supports program GRL by ensuring project management and...Directly supports program GRL by ensuring project management and regulatory operational support for the… more
- Takeda Pharmaceuticals (Boston, MA)
- …/ Purpose:** + Defines, develops and leads global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or ... adaptations to regulatory strategy. + Ensures project team colleagues, line management , and key stakeholders are apprised of developments that may impact … more
- Takeda Pharmaceuticals (Boston, MA)
- …medicines and make a lasting impact on patients worldwide. Join Takeda as a Director , Global Regulatory Lead Oncology where you will be part of the ... global regulatory team. As Director , Global ...area of responsibility. + Ensure project team colleagues, line management , and key stakeholders are apprised of developments that… more
- Takeda Pharmaceuticals (Boston, MA)
- …medicines and make a lasting impact on patients worldwide. Join Takeda as Associate Director , Global Regulatory Lead Oncology where you will be part of the ... global regulatory team. As Associate Director , Global ...Define, develop, and lead global strategies to maximize global regulatory success towards achievement of program objectives… more
- Rhythm Pharmaceuticals (Boston, MA)
- …and our tenacity to overcome barriers, together. Opportunity Overview In the Associate Director , Regulatory Affairs role, you will be responsible for ensuring ... the development and delivery of science-based, solution-oriented and internally aligned regulatory strategies for the program (s) under your accountability. You… more
- Lilly (Boston, MA)
- …is headquartered in Boston, Massachusetts. **The Position** The purpose of the Associate Director , Regulatory Strategy role is to support the development and ... for novel genome-editing development programs, including engagement with health authorities, management of program gaps and/or risks, and the preparation… 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 ... documentation and assures that Takeda labeling content and processes conform to regulatory requirements. ** Management of Local Exceptions and LOC Interactions**… more
- Takeda Pharmaceuticals (Boston, MA)
- …medicines and make a lasting impact on patients worldwide. Join Takeda as a Senior Director , Global Regulatory Lead - Oncology, where you will be part of the ... strategies with Leadership Team. Presents meaningful regulatory assessments and regulatory recommendations to management . + Ensure project team colleagues,… 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** Are ... control deliverables. + Contribute to product development and lifecycle management planning. + Provide regulatory impact assessments...single GRA point of contact for the medical device program and represents GRA at the Device Team, the… more
- Bristol Myers Squibb (Cambridge, MA)
- …at work and in their personal lives. Read more: careers.bms.com/working-with-us . **Sr Director , Global Regulatory Strategy, Neuroscience** + Will be a key ... Leadership Team to ensure the development, implementation, and alignment of regulatory strategies across projects and the Neuroscience therapeutic area. + Acts… more
- Prime Therapeutics (Boston, MA)
- …deficiencies are corrected; oversees CAP management and findings + Consults on regulatory change management process and program and advises on areas ... It fuels our passion and drives every decision we make. **Job Posting Title** Director , Compliance ( Regulatory ) - Remote **Job Description** The Director of… more
- Takeda Pharmaceuticals (Boston, MA)
- …are aligned with Takeda's strategic business requirements - including Master Data Management (MDM), Regulatory strategy, Industry standards, and evolving Health ... products, and systems are properly assessed, migrated, and governed within Takeda's Regulatory Information Management (RIM) ecosystem. The ideal candidate is a… more
- Takeda Pharmaceuticals (Boston, MA)
- … requirements, including eCTD4, SPOR/IDMP, and CTIS/EU CTR. + Oversee master data management for regulatory data and partner/ drive connectivity with RD and ... leadership, and other stakeholders for pipeline realization and post-approval lifecycle management . + Provide standard regulatory reports and dashboards and… more
- Takeda Pharmaceuticals (Boston, MA)
- …or enhances regulatory compliance. + Ensures project team colleagues, line management , and key stakeholders are apprised of developments that may impact ... identifies regulatory CMC risks, ensuring timely communication with line management . + Leads assigned global regulatory submissions (eg, Core Dossiers,… more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. The Associate Director , Global Regulatory Affairs Advertising and Promotion (GRA A&P) Review ... our growing Oncology Portfolio. You will be accountable for management of all assigned programs/products as the internal expert...GRA A&P SME for assigned products and projects. + Regulatory advisor as the "R" in the core Medical,… more
- Takeda Pharmaceuticals (Boston, MA)
- …true to the best of my knowledge. **Job Description** **Job Title:** Associate Director - Analytics, Global Regulatory Affairs **Role Purpose:** Strategic and ... operational oversight of custom analytics deliveries from Global Regulatory Affairs involving Business Intelligence solutions and related semantic layer… more
- Takeda Pharmaceuticals (Boston, MA)
- …company that will inspire you and empower you to shine? Join us as a Director , Global Program Management in our Cambridge office. At Takeda, we ... team members, stakeholder functions, and governance bodies. + Leverage program management best practices to facilitate cross-functional translational… more
- Prime Therapeutics (Boston, MA)
- …purpose-driven career? Come build the future of pharmacy with us. **Job Posting Title** Director , Project and Program Management - Remote **Job Description** ... The Director Project and Program Management is responsible for leading the...to their job, and comply with all applicable legal, regulatory , and contractual requirements and internal policies and procedures… more
