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Keywords: Regulatory Affairs Director, Location: Somerville, MA

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Regulatory Affairs Director

Job Description: Responsibilities Job Title: Regulatory Affairs Director Reports to: Head of Quality & Regulatory... and interactions with regulatory authorities. Essential Duties and Responsibilities As the Regulatory Affairs Director...

Company: RadNet
Location: Somerville, MA
Posted Date: 31 Dec 2025

Director, Regulatory Affairs and Quality Assurance

. As the Director of Regulatory Affairs & Quality Assurance (RA/QA), you will lead the strategy, execution, and continuous...: Bachelor's degree in life sciences, engineering, regulatory affairs, or a related field; advanced degree preferred. 8+ years...

Company: Whoop
Location: Boston, MA
Posted Date: 05 Dec 2025

Associate Director, Global Regulatory Affairs - Ad / Promo

(COVID-19 vaccine) is its first commercialized product. Position Summary The Associate Director, Regulatory Affairs... and strong collaboration with Commercial, Medical Affairs, Legal, Global Regulatory Affairs, Labeling and Compliance for the purpose...

Company: BioNTech
Location: Cambridge, MA
Posted Date: 22 Nov 2025
Salary: $166000 - 203000 per year

Associate Director, Regulatory Affairs

and modest costs. Description of Role Our Associate Director, Regulatory Affairs Reporting will be responsible for performing... Director, Regulatory Affairs, you will act as the regulatory lead on project teams, providing regulatory guidance and oversight...

Posted Date: 20 Nov 2025

Associate Director, Regulatory Affairs (CDx)

About the Job The Associate Director, Regulatory Affairs is responsible for supporting the regulatory function... Regulatory Affairs Team. Represent Regulatory Affairs department at cross-functional internal project meetings. May perform...

Location: Boston, MA
Posted Date: 11 Nov 2025
Salary: $175350 - 219200 per year

Director, Regulatory Affairs – Global Regulatory Strategy

Overview: Monte Rosa Therapeutics is seeking an experienced and strategic Director of Regulatory Affairs to lead..., or an advanced degree is preferred Minimum of 12 years of experience in global regulatory affairs within the pharmaceutical...

Location: Boston, MA
Posted Date: 26 Oct 2025

Associate Director, Regulatory Affairs - Contract

. What you’ll be doing As a key member of the Nuvation Regulatory Affairs team, you will collaborate with a cross-functional team...-on Regulatory Affairs professional to contribute to the development strategy and lead in the planning, preparation, submission...

Location: Boston, MA
Posted Date: 22 Dec 2025

Director, Global Regulatory Affairs CMC

: Independently develops and leads the execution of regulatory CMC investigational, registration and/or post-approval strategies... for assigned products as GRA CMC Product Lead. Represents and contributes to Regulatory, Pharmaceutical Development...

Company: Takeda
Location: Boston, MA
Posted Date: 25 Dec 2025

Senior Manager, Global Regulatory Affairs Strategy

Affairs Strategy, reporting to the Senior Director, Global Regulatory Affairs Strategy, you will provide regulatory strategy... Under the supervision of the Senior Director, Regulatory Affairs, contribute to planning and execution of regulatory...

Company: Olema Oncology
Location: Boston, MA
Posted Date: 04 Dec 2025
Salary: $176000 - 188000 per year

Senior Regulatory Affairs Manager

The Global Regulatory Affairs (GRA) is responsible for obtaining approval for new products and ensuring that approval... on how best to interpret the regulatory legislation and guidelines. The Regulatory Affairs Nonclinical / Clinical team plays a key role...

Posted Date: 21 Nov 2025

Regulatory Affairs Manager

Job Description: Responsibilities Job Title: Regulatory Affairs Manager Reports to: (Acting) Director, Regulatory... Affairs FLSA Status: Exempt Job Summary Reporting to the Director of Regulatory Affairs, the Regulatory Affairs Manager...

Company: RadNet
Location: Somerville, MA
Posted Date: 06 Nov 2025

Senior Director, Medical Affairs

a Senior Director of Medical Affairs to support our lead oncology program as it enters its first pivotal study. Reporting... Affairs teams, including MSLs and vendor management Knowledge of applicable global regulatory and compliance frameworks (FDA...

Location: Boston, MA
Posted Date: 19 Dec 2025

Senior Director, US Medical Affairs - Head of Rheumatology

: Join Takeda as the Senior Director, US Medical Affairs - Head of Rheumatology in Cambridge, MA. This is a critical role within the... standards of data privacy, ethics, and regulatory compliance in the application of AI within medical affairs activities...

Company: Takeda
Location: Cambridge, MA
Posted Date: 10 Dec 2025

Senior Director, Global Medical Affairs - Nephrology

Job Description General Summary: The Medical Affairs Senior Director provides medical and scientific leadership... impact of new research on scientific and medical understanding of assigned products Develops medical affairs plans...

Location: Boston, MA
Posted Date: 09 Dec 2025

Medical Director, Global Medical Affairs, Lupus

About This Role The Medical Director, Global Medical Affairs, Lupus will serve as a strategic physician leader... healthcare community. The Medical Director will collaborate closely across Biogen’s internal stakeholders and external...

Company: Biogen
Location: Cambridge, MA
Posted Date: 03 Dec 2025

Associate Director, External Scientific Partnerships – US Medical Affairs

Are you ready to make a difference in the world of rare diseases? As the Associate Director, External Scientific... Partnerships, US Medical Affairs, you will be at the forefront of strategic initiatives with US-based health professional societies...

Location: Boston, MA
Posted Date: 22 Nov 2025

Head (Executive Director) Rare Disease, US Medical Affairs

, accountable for the strategic direction and execution of medical affairs activities across the Rare Diseases portfolio... of Medical, North America. They will oversee a cross-functional medical team including Medical Directors, Field Director...

Company: Biogen
Location: Cambridge, MA
Posted Date: 15 Nov 2025

Medical Affairs Senior Director - Nephrology

Job Description General Summary: The Medical Affairs Senior Director provides medical and scientific leadership... of Nephrology medical plans. Key Duties and Responsibilities: Develops medical affairs plans, including Launch and Life Cycle...

Location: Boston, MA
Posted Date: 12 Nov 2025

Medical Affairs Senior Director, Oncology – Colorectal Cancer

: Join Takeda as the Medical Affairs Senior Director, Oncology – Colorectal Cancer. You will champion new and novel approaches... and alignment among internal partners on issues of potential impact to Takeda. You will report to the Head of US OBU Medical Affairs...

Company: Takeda
Location: Cambridge, MA
Posted Date: 30 Oct 2025

Medical Affairs, Medical Director - T1D

Job Description General Summary: The Medical Affairs Medical Director will provide medical leadership for T1D...-level critical thinking abilities are required. Key Duties and Responsibilities: Under direction of the Medical Affairs...

Location: Boston, MA
Posted Date: 24 Oct 2025