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Keywords: Senior Director, Regulatory Science, Location: Cambridge, MA

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Senior Director, Regulatory Science

Senior Director, Regulatory Science - Biologics & Cell and Gene Therapies Development Expertise This is a US & Global... Responsibilities: Regulatory Science Leadership: Manage a portfolio of clients: establish relationships with client, monitor client...

Posted Date: 15 Apr 2025

Senior Director, Regulatory Science

Job Description: Senior Director, Regulatory Science - Biologics & Cell and Gene Therapies Development Expertise... office. Key Responsibilities: Regulatory Science Leadership: Manage a portfolio of clients: establish relationships...

Posted Date: 12 Apr 2025

Senior Global Program Regulatory Manager (Early Development) - Associate Director Level

with regulatory agencies. Interacts and negotiates with regulatory agency personnel in order to expedite approval of pending... registration and answers any questions. Serves as a regulatory liaison on the project team throughout the product lifecycle...

Company: Novartis
Location: Cambridge, MA
Posted Date: 17 Apr 2025

Senior Medical Director, Clinical Science, GI2 TAU- Nephrologist

at Takeda. Join us as a Senior Medical Director, Clinical Science GI TAU- Nephrologist in our Cambridge, MA office. At Takeda... Director leads and drives strategy for the overall global (US/EU/Japan) clinical development taking into consideration the...

Company: Takeda
Location: Cambridge, MA
Posted Date: 13 Mar 2025

Senior Statistical Science Director (Hybrid)

where you will get personal and professional development. We are recruiting a Senior Statistical Science Director to join our growing... pharmaceutical companies. Join the team unlocking the power of what science can do. We are working towards treating, preventing...

Company: AstraZeneca
Location: Boston, MA
Posted Date: 22 Feb 2025

Senior Director, Clinical Science - Oncology

in accordance with the protocol, regulatory requirements, and ethical standards. This includes monitoring study progress, reviewing... of study-level documents, including protocol development, preparation of clinical sections of key regulatory documents...

Company: BioNTech
Location: Cambridge, MA
Posted Date: 02 Apr 2025

Senior Director, Translational Sciences Strategy & Quality Lead, Rare Diseases

internal and external specialty lab compliance with regulatory standards and patient protection regulations while driving the... generation of robust, reproducible data to support regulatory submissions. Oversee compliance of on-time completion of role...

Location: Boston, MA
Posted Date: 08 May 2025

Senior Director, Pharmaceutical Science Portfolio Strategy Lead

Governance advisory board, comprised of senior-level CMC experts to advise Pharm Sci teams towards winning CMC development...: Senior level R&D CMC portfolio strategy leader accountable for influencing and overseeing the Pharm Sci Portfolio Strategy...

Company: Takeda
Location: Boston, MA
Posted Date: 24 Apr 2025

Director, Global Regulatory Affairs (GRA) - CMC

Reporting to the Head of Regulatory Affairs CMC, the Director, Regulatory Affairs CMC will be responsible for leading... CMC regulatory activities that support the company’s product development strategies and providing guidance to broader CMC...

Company: The Steely Group
Location: Boston, MA
Posted Date: 10 Apr 2025

Regulatory Affairs Director, Global Regulatory Strategy

Position Summary: The Regulatory Affairs Director (RAD), Global Regulatory Strategy will be responsible for the... to date on latest regulatory requirements and trends, and contribute to the shaping of the regulatory science environment. Support...

Company: AstraZeneca
Location: Boston, MA
Posted Date: 08 Apr 2025

Director, Global Regulatory Affairs (GRA) – CMC

of Regulatory Affairs CMC, the Director, Regulatory Affairs CMC will be responsible for leading CMC regulatory activities... and stakeholders to resolve outstanding CMC regulatory issues Requirements: Bachelor's degree in a field of science...

Posted Date: 26 Mar 2025

Director, US Regulatory Affairs and Quality Management

Director of US Regulatory Affairs and Quality Management at Servier Pharmaceuticals, reporting to the Senior Director... function, and ensuring timely submissions are made to OPDP. The Director will proactively review regulatory guidelines...

Company: Servier
Location: Boston, MA
Posted Date: 07 Mar 2025

Sr Director, Regulatory Affairs

JOB TITLE: Senior Sales Operations Analyst LOCATION: Seaport, Boston, MA (hybrid 3 days in office) DEPARTMENT...: Business Analytics DATE PREPARED: 04/22/2025 JOB SUMMARY: The Senior Sales Operations Analyst will aid the continued...

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

Associate Medical Director, Clinical Science, Neuroscience Therapeutic Area- Neurology/Psychiatry

Director in our Neuroscience Therapeutic Area Unit in our Cambridge, MA office. ​ ​At Takeda, we are transforming the.... ​ ​Here, you will be a vital contributor to our inspiring, bold mission ​ ​POSITION OBJECTIVES: ​The Medical Director leads and drives...

Company: Takeda
Location: Cambridge, MA
Posted Date: 21 Mar 2025

Associate Medical Director, Clinical Science, GI TAU

Director, Clinical Science in our Gastrointestinal & Inflammation Therapeutic Area Unit in our Cambridge, MA office... ​ ​POSITION OBJECTIVES: ​The Associate Medical Director leads and drives strategy for the overall global clinical development...

Company: Takeda
Location: Cambridge, MA
Posted Date: 06 Mar 2025

Senior Clinical Research Director, Ophthalmology

Job Title: Senior Clinical Research Director, Ophthalmology Location: Cambridge, MA Morristown, NJ About the... for patients and their families. Your skills could be critical in helping our teams accelerate progress. The Senior Clinical...

Company: Sanofi EU
Location: Cambridge, MA
Posted Date: 10 May 2025

Senior Medical Director, Clinical Development, Nephrology

Senior Medical Director, Clinical Development Sciences Nephrology The Senior Medical Director, Clinical Development... and represents clinical development on the GPT, contributing to the development of regulatory strategy, and representing the clinical...

Location: Boston, MA
Posted Date: 07 May 2025

Senior Medical Director, Clinical Development Hematology

. Join us in our unique and ambitious world. The Role: The Senior Medical Director, Clinical Development Sciences Hematology may lead the... on the GPT, contributing to the development of regulatory strategy, and representing the clinical program at regulatory...

Location: Boston, MA
Posted Date: 07 May 2025

US Senior Marketing Director, Radioligand Therapy (RLT)

Job Title: US Senior Marketing Director, Radioligand Therapy (RLT) Location: Cambridge, MA About the Job In line... that could significantly improve outcomes for patients with limited therapeutic options. The US Senior Marketing Director will lead launch...

Company: Sanofi
Location: Cambridge, MA
Posted Date: 06 May 2025

Senior Director Clinical Pharmacology Lead

Senior Director Clinical Pharmacology Lead The Clinical Pharmacology Lead (CPL) Oncology will bring an extensive... for this role Senior Director Clinical Pharmacology Lead are to: Independently represent Clinical Pharmacology (CP) Oncology...

Company: Bayer
Location: Cambridge, MA
Posted Date: 02 May 2025