- Leica Biosystems (Boston, MA)
- …oncology environment. The Senior Principal, Regulatory Affairs will provide oversight and lead global submission work including in support of CDx trials and ... Biopharma sector.This position reports to the Director , Regulatory Affairs and is part of the Global...fully remote.In this role, you will have the opportunity to: Lead regulatory strategy and execution for external… more
- Takeda Pharmaceuticals (Boston, MA)
- …opportunities. + Partner with global market access colleagues to lead interactions with joint regulatory /health agency/HTA bodies on product specific ... Description** **_Objective / Purpose:_** + Defines, develops and leads global strategies to maximize global regulatory...oversees direct reports or other staff responsible. The Senior Director will lead all submission types. +… more
- Takeda Pharmaceuticals (Boston, MA)
- …Regulatory Teams (GRTs) and representing the regulatory function on cross-functional Global Program Teams. The Senior Director also will lead ... success for the mitigation strategies proposed. + The Sr Director / Director will be accountable for all US...Partner with global market access colleagues to lead interactions with joint regulatory /health agency/HTA bodies… more
- Takeda Pharmaceuticals (Boston, MA)
- …**How you will contribute:** + As our Associate Director , Global Regulatory Affairs Advertising and Promotion lead you will act as the Subject Matter ... possible in order to bring life-changing therapies to patients worldwide. The Associate Director , Global Regulatory Affairs Advertising and Promotion (GRA… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Director , Global Regulatory Affairs - Global Labeling Strategy **Location** : Morristown, NJ or Cambridge, MA (Hybrid) **About the Job** ... be critical in helping our teams accelerate progress. The Director , Global Regulatory Affairs -...Represent Global Labeling on global regulatory teams and labeling sub-teams; lead labeling-related… more
- Takeda Pharmaceuticals (Boston, MA)
- …is possible in order to bring life-changing therapies to patients worldwide. The Director Global Regulatory Affairs, Neuroscience is responsible for ... reports or junior colleagues executing these tasks. The Associate Director will lead highly complex submission types...Partner with global market access colleagues to Lead interactions with joint regulatory /health agency/HTA bodies… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Associate Director , Global Regulatory Affairs - Global Labeling Strategy **Location** : Morristown, NJ or Cambridge, MA (Hybrid) **About ... critical in helping our teams accelerate progress. The Associate Director , Global Regulatory Affairs -...was possible. Ready to get started? **Main Responsibilities** + Lead the preparation, review, and maintenance of global… more
- Takeda Pharmaceuticals (Boston, MA)
- … Global Regulatory Affairs CMC team, you will report to the Senior Director Global Regulatory Affairs CMC. **How you will contribute:** + Plan, ... CMC related matters. + Proven ability to liaise with Regulatory Agencies, having served as lead in...international experience preferred. + Understanding of scientific principles and regulatory CMC requirements relevant to global drug… more
- Takeda Pharmaceuticals (Boston, MA)
- …Management** + Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies ... possible in order to bring life-changing therapies to patients worldwide. Join Takeda as Director , Global Regulatory Labeling Strategy where you will be… more
- Takeda Pharmaceuticals (Boston, MA)
- …development of scientific communications strategy and deliverables, the **Associate Director , Scientific Communications Lead , Hematology** proactively defines ... empowered to deliver your best. As part of the Global Medical Affairs Oncology team, you will report to...life sciences, and excellent project management skills. The Associate Director , Scientific Communications Lead , develops and implements… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Sr. Director , Global Market Access and Pricing Lead - Oncology **Location:** Cambridge, MA **About the Job** Sanofi Genzyme's Oncology ... and prepare for pipeline future launches. The primary purpose of the role is to lead development, update and execution of the Global Market Access and Pricing… more
- Takeda Pharmaceuticals (Boston, MA)
- …Autonomy + Responsibility in line with Associate Director level position; independently lead HE projects and support the Global Health Economics Center of ... appropriate comparator + Co- lead with Market Access the development of the global value proposition to ensure a compelling value story for payers + Identify and… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …+ Comprehensive understanding of the pharmaceutical industry and medical affairs + Global regulatory expertise with demonstrated strong ability for collaboration ... best of my knowledge. **Job Description** **Role Objectives:** + The Group Lead , Global Scientific Communications has ultimate accountability for delivering and… more
- Rhythm Pharmaceuticals (Boston, MA)
- … Global Regulatory Affairs. Responsibilities and Duties + Act as the Global Regulatory Lead on multi-disciplinary project teams and provide strategic ... to overcome barriers, together. Opportunity Overview In the Associate Director , Regulatory Affairs role, you will be...execution of regulatory filings, maintaining compliance with global regulatory standards and commitments. You will… more
- Takeda Pharmaceuticals (Boston, MA)
- …what is possible in order to bring life-changing therapies to patients worldwide. The Director Regulatory Site CMC ensures efficient and compliant management of ... with external manufacturing sites and suppliers to align change control processes with global regulatory expectations. + Ensure site compliance with global … more
- Philips (Cambridge, MA)
- …of all Software/Artificial Intelligence platforms for the Ultrasound business. **Your role:** + Lead a global Regulatory Affairs team for end-to-end ... Software and Artificial Intelligence (Ultrasound)** The Director , Regulatory Affairs-SW and AI will lead the...the hiring and development of critical talent within the global regulatory affairs team through creating and… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …used for meeting presentations and formal responses to communications received from the regulatory organizations or opinion leaders. + Lead roles will also be ... Description** **OBJECTIVES:** + Leads flagships medical programs as defined by the Global Medical Affairs (GMA) Strategy Team and sub-teams + Leads GMA-driven… more
- CBRE (Boston, MA)
- Regulatory Change Management Director Job ID 215809 Posted 21-Apr-2025 Service line Corporate Segment Role type Full-time Areas of Interest Legal Location(s) ... United States of America **About The Role:** As a Regulatory Change Management Director at CBRE, you...with 8-12 years of relevant experience. + Ability to lead the exchange of sensitive, complicated, and difficult information,… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- In this key leadership role, you will build and oversee Global Regulatory Science and Regulatory CMC strategic framework and will support driving ... cell transplant. In this position you will build and lead a cell medicine regulatory affairs team...Responsible for the strategic company guidance on FDA and global regulatory requirements (affairs and CMC) for… more
- Takeda Pharmaceuticals (Boston, MA)
- …**Job Description** **Objective / Purpose:** The Head of Design & Delivery, Development & Regulatory will lead the global technical product strategy across ... design through regulatory submissions to post-market safety surveillance. You will lead a global team of product managers and work cross-functionally to… more
