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

Page: 1

Director of Finance

of financial and operational efficiency. We are seeking a Director of Finance to lead our financial strategy, reporting..., Director of Purchasing, and Director of IT, ensuring compliance with all regulatory requirements and optimizing financial...

Location: Boston, MA
Posted Date: 08 Mar 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: 08 Mar 2025

Senior Director, Regulatory Strategy

Job Description General Summary: The Senior Director, Regulatory Strategy, is a regulatory leader with expert... technical and tactical experience in global regulatory strategy and will be responsible for overseeing the development...

Location: Boston, MA
Posted Date: 27 Feb 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: 29 Jan 2025

Director, Regulatory Affairs Strategy

of person. Cardiovascular, Renal & Metabolism - Regulatory Science and Strategy AstraZeneca’s pipeline of innovative... is a respected voice and considered an equal partner in the business. The Regulatory Affairs Director (RAD) provides strategic...

Company: AstraZeneca
Location: Boston, MA
Posted Date: 23 Jan 2025

Director, Regulatory Affairs - Small Molecule Strategy

to join our team as an Director of Regulatory Affairs. This role will focus on oncology, immunology, and related therapeutic areas. The... and approval of our innovative therapies. Responsibilities: The Associate Director of regulatory Affairs will be responsible...

Location: Boston, MA
Posted Date: 22 Jan 2025

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: 05 Jan 2025

Associate Director, Regulatory Labeling Strategy (Remote)

has responsibility for leading labeling strategy and coordinating development of the Target Label Profile (TLP) with the cross-functional..., as necessary, to advise on potential labeling impact, strategy, or outcome. Lead the Label Working Group (LWG) for assigned...

Location: Boston, MA
Posted Date: 15 Feb 2025

Director, Regulatory Affairs CMC

. Job Description The Director, Regulatory Affairs CMC will be responsible for the development, strategy, execution and tracking of CMC... regulatory activities for assigned BicycleTx programs or projects. The Director, Regulatory Affairs CMC will be responsible...

Location: Cambridge, MA
Posted Date: 07 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

Director, Global Regulatory Lead, GI & Inflammation

of global regulatory strategies in collaboration with their regional counterparts. Accountabilities: The Director... tactical guidance to teams and collaborates cross-functionally to ensure the global regulatory strategy is updated and executed...

Company: Takeda
Location: Boston, MA
Posted Date: 27 Feb 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: 21 Feb 2025

Senior Director, Global Regulatory Lead, GI & Inflammation

regulatory strategy is updated and executed, ensuring global regulatory compliance and/or oversees direct reports or junior staff... with changing regulatory and business needs and anticipates such changes to lead adaptations to regulatory strategy. Ensures...

Company: Takeda
Location: Boston, MA
Posted Date: 20 Feb 2025

Associate Director, Global Regulatory Lead, GRAD Oncology

of what is possible in order to bring life-changing therapies to patients worldwide. Join Takeda as Associate Director Global Regulatory Lead... Associate Director, you will be responsible for complex or highly complex or multiple projects. May lead the Global Regulatory...

Company: Takeda
Location: Boston, MA
Posted Date: 14 Feb 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: 18 Jan 2025

Executive Director, Regulatory Affairs - Cell Medicine

In this key leadership role, you will build and oversee Global Regulatory Science and Regulatory CMC strategic..., and novel conditioning / lymphodepletion options. In this position you will provide regulatory leadership and oversight to the...

Posted Date: 11 Jan 2025

Director, Global Regulatory Lead, GI & Inflammation

of global regulatory strategies in collaboration with their regional counterparts. Accountabilities: The Director... tactical guidance to teams and collaborates cross-functionally to ensure the global regulatory strategy is updated and executed...

Company: Takeda
Location: Boston, MA
Posted Date: 08 Jan 2025

Senior Regulatory Legal Counsel, Director (Hybrid)

: Regulatory Strategy, Labeling & CMC, Regulatory Policy, Regulatory Intelligence, Federal Government Affairs, Safety, and Quality... approval), regulatory strategy for new products and line extensions, Hatch Waxman issues and life cycle management, and design...

Location: Boston, MA
Posted Date: 06 Mar 2025

Associate Director, Regulatory Affairs Vaccines CMC

Provides program leadership and develops CMC regulatory strategy in support of global vaccine programs in various stages... of development Represents the vaccine regulatory affairs team on cross-functional Takeda Vaccines teams to ensure that data...

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

Regulatory affairs Labelling Director

Responsibilities: Lead cross-functional labeling teams, driving alignment on strategy and content. Provide strategic... with Global Regulatory Leads and escalate issues when necessary, proposing risk mitigation strategies. Requirements: 10...

Posted Date: 13 Feb 2025