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Keywords: Director/ Senior Director, Regulatory Affairs Operations, Location: Boston, MA

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Director/ Senior Director, Regulatory Affairs Operations

of Regulatory Affairs Operations to join our team. This key leadership role is ideal for a seasoned Regulatory Operations leader who..., you will oversee regulatory operations activities across development programs, ensuring compliant, efficient, and timely regulatory...

Company: enGene
Location: Boston, MA
Posted Date: 11 Sep 2025

Director, Global Regulatory Affairs

Title: Director, Global Regulatory Affairs Company: Ipsen Innovation (SAS) About Ipsen: Ipsen is a mid-sized... on and . Job Description: WHAT - Summary & Purpose of the Position The Director of Global Regulatory Affairs is responsible for developing and implementing...

Company: Ipsen
Location: Cambridge, MA
Posted Date: 27 Aug 2025

Executive Director, Regulatory Science

Location: Boston, MA Main responsibilities The Executive Director (ED) Regulatory Science will actively support..., and serve as senior advisor to, the program regulatory teams to define Orchard’s US regulatory strategies across the pipeline...

Location: Boston, MA
Posted Date: 09 Sep 2025

CMC Product Leader, Senior Director - Biologics

Job Description The Senior Director, CMC Product Leader, Biologics, will lead CMC functional teams of one or multiple... will report into the Executive Director, Project Management and Strategic Operations for Biopharmaceutical Sciences-CGT. It...

Location: Boston, MA
Posted Date: 20 Sep 2025

Senior Medical Director, Oncology Clinical Development (Office Based - Cambridge, MA)

. Cross-functional Collaboration: Work closely with regulatory affairs, clinical operations, pharmacovigilance, biostatistics..., and long-term growth. Job Description The Senior Medical Director will lead late-stage clinical development programs...

Company: Zai Lab (US) LLC
Location: Cambridge, MA
Posted Date: 13 Sep 2025

Senior Medical Director, Clinical Development Neurology

and planning bet medical functions (Global Medical Affairs, Safety, Clinical Operations, Biostatistics, Epidemiology and Medical... in Human study stage to Proof of Concept /Phase2 stage, Phase 3 and regulatory approval ). You will be responsible...

Location: Boston, MA
Posted Date: 23 Sep 2025

Sr. Director, US Alzheimer's Diagnostic Strategy and Commercialization

About This Role: In this pivotal position at Biogen, as Senior Director of U.S. Diagnostic Strategy... trials through collaboration with Medical Affairs. Integrate diagnostics into market execution with Marketing, Field Teams...

Company: Biogen
Location: Cambridge, MA
Posted Date: 07 Sep 2025

Director of Pharmacy Benefit Manager Oversight

About the Organization: The Division of Insurance ("DOI"), an Agency within the Office of Consumer Affairs..., and empowered to maximize their skills and talents to serve our citizens. About the Role: The Director of Pharmacy Benefit...

Posted Date: 21 Aug 2025

Medical Director

JOB TITLE: Medical Director, Oncology REPORTS TO: Senior Vice President, Head of Clinical Development DATE PREPARED..., and interpretation of Phase I clinical studies. ·Collaborate with cross-functional teams, including clinical operations, regulatory...

Company: AVEO Oncology
Location: Boston, MA
Posted Date: 03 Aug 2025

Associate Director, Biostatistics

, clinical operations, medical writing, regulatory affairs, IT, and external partners to drive strategic alignment and execution... and regulatory requirements. In addition to managing internal teams and external partners, the Associate Director plays a pivotal...

Company: Ipsen
Location: Cambridge, MA
Posted Date: 31 Jul 2025

Oncology Early Stage Clinical Scientist (Director, Non-MD)

collaborations with key internal and external partners, such as project leaders, research units, biostatistics, regulatory affairs... with and solid understanding of related disciplines, e.g., Clinical Operations, Safety, Biostatistics, Regulatory, Study Management...

Company: Pfizer
Location: Cambridge, MA
Posted Date: 13 Sep 2025

Manager/ Sr. Manager, Study Operations, Nonclinical Toxicology

members, regulatory leads, and senior management in order to advance drug candidates through research and development... and modest costs. Description of Role The Study Operational manager will manage and oversee day-to-day operations...

Posted Date: 19 Sep 2025

Senior Manager, Clinical Supply Chain

with Clinical Operations, CMC, Quality, and Regulatory Affairs to align on assumptions, ensuring robust supply availability... will report directly to the Senior Director, Supply Chain and will be responsible for ensuring that our investigational therapy...

Location: Boston, MA
Posted Date: 25 Sep 2025

Government Pricing Compliance Senior Manager

, reporting to the Senior Director of Government Pricing within the US Market Access department. This rapidly expanding function... Operations, GTN, Accounting/Finance, US Public Affairs, Legal, Audit, Commercial leaders, and external Legal and consultants...

Location: Boston, MA
Posted Date: 20 Sep 2025

Deputy Commissioner of Public Safety

, Operations, and Policy on Agency procurements. External Affairs Coordinate with senior staff on legislation, policy...About the Organization: The Division of Occupational Licensure (DOL), an agency within the Office of Consumer Affairs...

Posted Date: 28 Aug 2025