- 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
- Dana-Farber Cancer Institute (Brookline, MA)
- …work remotely from a New England state (ME, VT, NH, MA, CT, RI).** The Regulatory Compliance Director is a key part of the Compliance team, collaborating across ... federal and state healthcare laws, payer requirements and internal policies. The Regulatory Compliance Director is responsible for developing, implementing, and… 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)
- …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
- 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)
- …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)
- …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
- Bristol Myers Squibb (Cambridge, MA)
- …and in their personal lives. Read more: careers.bms.com/working-with-us . **Position Summary** The Director , Program Management , is assigned to early and/or ... the rigorous execution of the IDP individually or in partnership with assigned Program Management team members. **Duties/Responsibilities** + Program … more
- Bristol Myers Squibb (Cambridge, MA)
- …personal lives. Read more: careers.bms.com/working-with-us . **Position Summary** The Senior Director , Program Management Lead (individual contributor) is ... rigorous execution of the IDP through matrix or line management of Program Management team...all phases of research and drug development, including global regulatory submissions (IND/CTA through NDA/BLA/MAA/JNDA/ NDA China) and lifecycle… 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 ... Clinical Operations, Research, Regulatory , CMC, Marketing) + 10+ years program management experience leading complex pharmaceutical projects in a… more
- Amgen (Cambridge, MA)
- …team. Join us and transform the lives of patients while transforming your career. ** Director , Commercial Drug Products & Life Cycle Management ** **What you will ... supply of commercial drug products. We are seeking a director to lead an impactful team of DPTLs responsible...and implement strategy for commercial drug product programs, life-cycle management , global regulatory submissions, and variation … more
- Takeda Pharmaceuticals (Cambridge, MA)
- …is true to the best of my knowledge. **Job Description** **Associate Director , Lifecyle Management , GI and Inflammation Business Unit (GIBU)** **Takeda ... Pharmaceutical** **Cambridge, MA** **About the role:** Join Takeda as the Associate Director , Lifecyle Management , GIBU, where you will lead efforts to maximize… more