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Keywords: Director, Regulatory Affairs CMC, Location: Cambridge, MA

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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

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

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.... This position will be responsible for auditing/reviewing regulatory submissions, working closely with the Regulatory Affairs...

Location: Boston, MA
Posted Date: 18 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

Executive Director, Regulatory Affairs - Cell Medicine

development of innovative regulatory affairs and CMC regulatory strategies, guidance and play a critical role overseeing the... regulatory requirements (affairs and CMC) for investigational and commercial products Develop and maintain health authority...

Posted Date: 11 Jan 2025

Director, Regulatory Submission Management (Boston)

Affairs groups including Regional Regulatory Leads, Regulatory CMC, Labeling, Advertising and Promotion, Regulatory Operations...Job Description General Summary: The Director, Regulatory Submission Management is accountable for the oversight...

Location: Boston, MA
Posted Date: 08 Mar 2025

Senior Regulatory Legal Counsel, Director (Hybrid)

: Regulatory Strategy, Labeling & CMC, Regulatory Policy, Regulatory Intelligence, Federal Government Affairs, Safety, and Quality...Job Description General Summary: The primary purpose of the Senior Regulatory Legal Counsel is to independently...

Location: Boston, MA
Posted Date: 06 Mar 2025

Associate Director Clinical Scientist Immunology Cell Therapy

, Regulatory Affairs, Clinical Operations, Translational, CMC, and early development groups. Your scientific input will support the... both strategic and operational leadership skills? If so, we invite you to join us! We are currently seeking a Director Clinical...

Company: AstraZeneca
Location: Boston, MA
Posted Date: 19 Feb 2025

Medical Director/Senior Medical Director, Clinical Development (Remote)

and regulatory affairs to ensure alignment on program objectives Lead the development of scientific publications, presentations... of life for patients, caregivers, and families. Job Description The Medical/Senior Medical Director will play a key role...

Company: Glycomine
Location: Boston, MA
Posted Date: 15 Feb 2025

Medical Director/Senior Medical Director, Clinical Development (Remote)

and regulatory affairs to ensure alignment on program objectives Lead the development of scientific publications, presentations... of life for patients, caregivers, and families. Job Description The Medical/Senior Medical Director will play a key role...

Company: Glycomine
Location: Boston, MA
Posted Date: 13 Feb 2025

Director Clinical Scientist Immunology Cell Therapy

, Regulatory Affairs, Clinical Operations, Translational, CMC, and early development groups. Your expert scientific input..., regulatory, safety, CMC, commercial operations. Experience proactively integrates multiple perspectives into the clinical...

Company: AstraZeneca
Location: Boston, MA
Posted Date: 29 Jan 2025

Global Lead Buyer - Advanced Sourcing

: Collaborate closely with R&D, Manufacturing, Quality Assurance, Regulatory Affairs, and other relevant stakeholders to ensure...Job Title: Senior Director, Global Lead Buyer - Advanced Sourcing Location: Bridgewater NJ, Morristown NJ...

Company: Sanofi
Location: Cambridge, MA
Posted Date: 14 Feb 2025