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Keywords: Director, Regulatory Strategy, Location: Boston, MA

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Director, Regulatory Strategy, Pain

Job Description General Summary: The Regulatory Strategy Director will be responsible for the development.... This position will play a major role in shaping cohesive regulatory strategy for assigned programs and ensuring effective...

Location: Boston, MA
Posted Date: 10 Apr 2025

Director, Regulatory Strategy

Job Description General Summary: The Regulatory Strategy Director will be responsible for the development... will play a major role in shaping cohesive regulatory strategy for assigned program(s) and ensuring effective integration...

Location: Boston, MA
Posted Date: 10 Apr 2025

Associate Director, Regulatory Labeling Strategy (Remote)

Job Description General Summary: The Regulatory Labeling Associate Director will be responsible for strategic... (IFUs). Contributes to labeling strategy with a proficient ability to advise stakeholders of regulatory labeling...

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... strategy and other critical regulatory documents. May represent Alexion as point contact with relevant Health Authorities...

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

Sr. Manager/Associate Director, Regulatory Affairs Strategy - Labeling

Sr. Manager/Associate Director, Regulatory Affairs Strategy – Labeling Who we are: is a biopharmaceutical company... Pharmaceuticals is searching for a Senior Manager/Associate Director of Regulatory Affairs Strategy - Labeling to join our growing...

Company: Agios
Location: Cambridge, MA
Posted Date: 28 Jan 2025

Manager, Global Regulatory Strategy US & Canada - Neuroscience (Onsite Hybrid)

, Director (Global Regulatory Lead (GRL)), in the development and execution of the regulatory strategy. Assigned matters may..., company policies, procedures, and guidance in alignment with regulatory product strategy and the Quality Dossier Program (QDP...

Company: AbbVie
Location: Cambridge, MA
Posted Date: 22 Apr 2025

Director, Global Regulatory Lead, Plasma-Derived Therapies R&D

regulatory strategy and coordinating life cycle activities across the portfolio of PDT products. The Global Regulatory Lead..., Director, in PDT R&D: Serves as the global regulatory lead for one or more projects and and includes leadership of the Global...

Company: Takeda
Location: Boston, MA
Posted Date: 17 Apr 2025

Snr Director Regulatory Science

Regulatory Science, Snr Director This is a US & Global Regulatory leadership role that will see you driving... regulatory strategy, client engagement, team leadership, continuous improvement initiatives and being a cultural and commercial...

Posted Date: 15 Apr 2025

Associate Regulatory Affairs Director

Associate Regulatory Affairs Director Introduction to role The Associate Regulatory Affairs Director (ARAD..., coordination, and execution of assigned deliverables. The ARAD is a key contributor to regulatory submission strategy, identifying...

Company: AstraZeneca
Location: Boston, MA
Posted Date: 13 Apr 2025

Snr Director Regulatory Science

Job Description: Regulatory Science, Snr Director This is a US & Global Regulatory leadership role... that will see you driving regulatory strategy, client engagement, team leadership, continuous improvement initiatives and being a cultural...

Posted Date: 12 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... development of CMC regulatory strategy for assigned programs, identifying key issues, necessary remediation activities...

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

Senior Director, Talent Acquisition, Regulatory & Quality and G&A

Job Description General Summary: The Sr. Director, Talent Acquisition is an experienced Talent Acquisition expert... senior Talent Acquisition Leadership team, s/he would provide vision, leadership and team management for Regulatory & Quality...

Location: Boston, MA
Posted Date: 10 Apr 2025

Senior Director, Regulatory Affairs Advertising & Promotion

Job Description General Summary: The Senior Director, Global Regulatory Affairs Advertising Promotion... is responsible for providing commercial regulatory strategy and oversight in the development, review and approval of product...

Location: Boston, MA
Posted Date: 10 Apr 2025

Director, Engineering and Data Governance- Clinical, quality and regulatory

, quality and regulatory areas. As the Director of Engineering and Data Governance, you will report to the Sr. Director of DSE... Partner with DTE Leadership to develop and execute data and analytics strategy aligned to the clinical, quality and regulatory...

Location: Boston, MA
Posted Date: 10 Apr 2025

Senior Director, Regulatory Labeling

Job Description General Summary: The Senior Director, Regulatory Labeling is regulatory labeling leader with expert... technical and operational experience in regulatory labeling, globally, and is responsible for overseeing the development...

Location: Boston, MA
Posted Date: 10 Apr 2025

QA Associate Director, CMC Regulatory Submission QC and Audit

Job Description The QA Associate Director, CMC Regulatory Submission QC and Audit, is responsible for the audit... and Responsibilities: Engages with relevant stakeholders to develop a holistic Quality strategy for regulatory submission audits Serves...

Location: Boston, MA
Posted Date: 09 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... achieving the department/corporate objectives. Essential Functions: Lead the development of CMC regulatory strategy...

Posted Date: 26 Mar 2025

Associate Director, Regulatory Affairs

Associate Director, Regulatory Affairs role, you will be responsible for ensuring the development and delivery of science-based... regulatory strategy and initiatives for your assigned programs. By joining our growing and dynamic regulatory affairs team...

Location: Boston, MA
Posted Date: 20 Mar 2025

Director, US Regulatory Affairs - Advertising and Promotion

Job title: Director, US Regulatory Affairs - Advertising and Promotion Location: Cambridge, MA or Morristown, NJ.... In at least one product area, you will be considered the resident expert in Global Regulatory Affairs Region NA, Advertising & Promotion (A&P...

Company: Sanofi
Location: Cambridge, MA
Posted Date: 19 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