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Keywords: Regulatory Affairs Manager, Location: Boston, MA

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

(RSTP) for assigned on market products or those products in development. The Manager assists Regulatory Staff by identifying... contribute to regulated communication on Regulatory/FDA issues including Public Affairs, Clinical Development, Legal...

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

Regulatory Diagnostics Manager/ Senior Regulatory Diagnostics Manager

Job Description Summary The Regulatory Diagnostics Manager (RDM) for Precision Diagnostics is responsible... Regulatory Affairs Precision Diagnostics Team including the TA and Diagnostics Lead on strategies and submissions including...

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

Senior Manager, Regulatory CMC, Cell & Gene Therapy

and Experience: Bachelor's Degree in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices...Job Description General Summary: The Chemistry Manufacturing Controls Senior Manager will participate in the...

Location: Boston, MA
Posted Date: 10 Apr 2025

Sr. Manager, Regulatory Operations

Sr. Manager, Regulatory Operations Who we are: is a biopharmaceutical company that is fueled by connections... you will make: Agios Pharmaceuticals is searching for a dynamic Senior Manager of Regulatory Operations to join our growing...

Company: Agios
Location: Cambridge, MA
Posted Date: 13 Feb 2025

Medical Affairs, Associate Medical Director - CF (Hybrid, Boston)

Affairs organizations, GAPP and Corporate Communications, Legal, Compliance (OBIE), Regulatory, Research & Development, HRBP...Job Description General Summary: The Medical Affairs Associate Medical Director will provide medical leadership...

Location: Boston, MA
Posted Date: 10 Apr 2025

Medical Affairs Strategy Medical Director - Pain (Boston)

Affairs organizations, GAPP and Corporate Communications, Legal, Compliance (OBIE), Regulatory, Research & Development, HRBP...Job Description General Summary: The Medical Affairs Medical Director will provide medical leadership for the...

Location: Boston, MA
Posted Date: 10 Apr 2025

Medical Affairs Strategy, Senior Medical Director - Heme (Hybrid)

Job Description General Summary: Vertex seeks a dynamic and experienced Medical Affairs Physician/ Senior Medical... Director for our Disease Area of Hematology within the Medical Affairs Strategy group. This individual will be responsible...

Location: Boston, MA
Posted Date: 10 Apr 2025

Vice President of External Affairs

Communicates Collaboratively Displays Authenticity and Transparency Position Summary The Vice President of External Affairs..., and federal). Role & Responsibilities * Public Affairs: Develop and implement GBFB’s government affairs strategy covering...

Posted Date: 23 Mar 2025

Director, Regulatory CMC - Cell & Gene Therapy

committees Education and Experience: Bachelor's, Master's or PhD degree in Biology, Chemistry, Pharmacy, Regulatory Affairs...Job Description General Summary: The Director, Regulatory CMC leads a cross-functional team in the execution...

Location: Boston, MA
Posted Date: 19 Apr 2025

Regulatory Strategist

Job Title: Regulatory Strategist Grade: L3-2 Hiring Manager: Olaf Mengels Location: Cambridge, MA About the..., including at least 4 years of relevant Regulatory Affairs experience (regional and global), in early and late stage, development...

Company: Sanofi
Location: Cambridge, MA
Posted Date: 11 Apr 2025

Director, Regulatory Strategy, Pain

as needed Counsels and advises or seek for alignment with GRA leadership on status of global Regulatory Affairs strategies, critical..., supervising junior regulatory associates and GRA fellows. Knowledge and Skills: Experienced in Regulatory Affairs strategy...

Location: Boston, MA
Posted Date: 10 Apr 2025

Director, Regulatory Strategy

Authority communications Counsels and advises GRA leadership on status of global Regulatory Affairs strategies and tactics...(s) or projects with moderate resource requirements or complexity Knowledge and Skills: Experienced in Regulatory Affairs...

Location: Boston, MA
Posted Date: 10 Apr 2025

Senior Director, Regulatory Labeling

within regulatory affairs and 5 years of supervisory/management experience, or the equivalent combination of education and experience...Job Description General Summary: The Senior Director, Regulatory Labeling is regulatory labeling leader with expert...

Location: Boston, MA
Posted Date: 10 Apr 2025

Associate Director, Regulatory Labeling Strategy (Remote)

: Bachelor’s degree, with a preference in a life sciences field Typically requires 8 years of experience in regulatory affairs...Job Description General Summary: The Regulatory Labeling Associate Director will be responsible for strategic...

Location: Boston, MA
Posted Date: 09 Apr 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: 09 Apr 2025

Senior Manager, Hemophilia Franchise Marketing

Job Title: Senior Manager, Hemophilia Franchise Marketing Location: Cambridge, MA About the Job The Senior... Product Manager, Hemophilia Franchise Marketing will be responsible for supporting a cohesive strategy across the team...

Company: Sanofi
Location: Cambridge, MA
Posted Date: 01 May 2025
Salary: $122250 - 176583.33 per year

Senior Manager of Behavioral Health Program Performance

direction of the Senior Director of Behavioral Health Programs and Strategy, the Senior Manager of BH Program Performance... clinical departmental staff and external regulatory and key stakeholder contacts as appropriate related to the tracking...

Location: Boston, MA
Posted Date: 01 May 2025

Chemistry Manufacturing Controls Manager

Job Description General Summary: The Regulatory Affairs Chemistry Manufacturing Controls (CMC) Manager..., Regulatory Affairs for Drugs, Biologics or Medical Devices, or another related life-science field Typically requires 4 years...

Location: Boston, MA
Posted Date: 01 May 2025
Salary: $122600 - 183900 per year

Clinical Project Manager (Remote)

Development, Regulatory Affairs, Translational Medicine and Program Leadership to ensure alignment on clinical trial objectives... Manager is a team-player role responsible for supporting aspects of clinical operations for our programs. This individual...

Company: Glycomine
Location: Boston, MA
Posted Date: 30 Apr 2025

Patient Safety ARRM Manager

in applicable aggregate safety reports Collaborates with Regulatory Affairs and other functions to coordinate submission...Job Description General Summary: The Patient Safety Aggregate Reports and Risk Management (ARRM) Manager...

Location: Boston, MA
Posted Date: 26 Apr 2025
Salary: $120000 - 179900 per year