Regulatory Affair Specialist jobs in Waltham, MA

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REGULATORY AFFAIRS DIRECTOR, ONCOLOGY

Lead cross functional teams in major regulatory submissions (NDA/BLA/IND/CTA), health authority interactions, label discussions, and securing approvals.. Develop and implement the program's regional or global strategy ensuring tha...

CompanyAstrazeneca
AddressWaltham, MA
CategoryInformation Technology
Date Posted 3 weeks ago See detail

Regulatory Affairs Director, Oncology

Astrazeneca

Waltham, MA

Lead cross functional teams in major regulatory submissions (NDA/BLA/IND/CTA), health authority interactions, label discussions, and securing approvals.. Develop and implement the program's regional or global strategy ensuring tha...

SVP, Global Regulatory Affairs

Biospace

Waltham, MA

Ensure the development, preparation, and implementation of global strategic regulatory plan for all programs and product pipeline designed to maximize successful and expedient global product registrations. Responsible for managing...

Director, Regulatory Affairs Vaccines CMC

Biospace

Boston, MA

Lead planning, execution, and management of regulatory submissions for assigned vaccines in various phases of clinical development, global marketing applications, and post-approval life cycle activities, as needed. Participate in...

Senior Director/Director, Global Regulatory Affairs Early Respiratory & Immunology

Astrazeneca

Boston, MA

Work on cross-project initiatives of high importance for the early R&I portfolio. Lead the development and implementation of innovative global strategies of increasing complexity to improve the likelihood of regulatory success. Ac...

Manager, Global Regulatory Affairs CMC

Biospace

Boston, MA

I further attest that all information I submit in my employment application is true to the best of my knowledge.Takeda Development Center Americas, Inc. is seeking a Manager, Global Regulatory Affairs CMC in Cambridge, MA with the...

Manager, Regulatory Affairs CMC

Biospace

Boston, MA

I further attest that all information I submit in my employment application is true to the best of my knowledge.Takeda Development Center Americas, Inc. is seeking a Manager, Global Regulatory Affairs CMC in Cambridge, MA with the...

Regulatory Risk Managment Specialist

Northern Trust

Boston, MA

Unspecified

Regulatory Framework & Governance. Regulatory Change Oversight. Regulatory Risk Management. Regulatory Strategy & Sustainability. Actively support the embeddedness of the regulatory change framework and relevant regulatory account...