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Director, Regulatory CMC, Cell & Gene Therapy (Boston)

Vertex Pharmaceuticals
Boston, MA
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Job Description General Summary: The Director, Regulatory CMC (Chemistry ...
Details
Summary
About the job:
Manufacturing Controls) is responsible for the development and implementation of post-approval global regulatory CMC strategies for a marketed cell and gene therapy product. This role provides regulatory guidance to various cross-functional teams to ensure all applicable global regulatory requirements are considered and appropriately incorporated into a marketed cell and gene therapy product. Key Duties and Responsibilities: - Oversees the preparation and review of CMC sections of regulatory submissions, and supports the...
Location:
Boston, MA
Job Type:
Full-Time
Permanent
Occupation:
Regulatory Affairs Managers
Career Level / Education:
High school diploma or equivalent
Salary:
Six Figure Jobs (more than $100K)
Certifications / Licenses:
N/A
Workkeys
Applied Math
4
Graphic Literacy
4
Workplace Documents
5
apply
Detailed Job Information

Director, Regulatory CMC, Cell Therapy Combination Product (Boston)

Vertex Pharmaceuticals
Boston, MA
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Job Description General Summary: The Director, Regulatory CMC (Chemistry ...
Details
Summary
About the job:
Manufacturing Controls) leads a cell therapy combination product program from development through commercialization through the execution of global regulatory CMC strategies for investigational and marketed products. This role is accountable for the preparation and filing of regulatory CMC submissions and managing the interactions with Health Authorities for CMC topics. This role provides regulatory guidance to various cross-functional teams to ensure all applicable global regulatory requirements are considered and...
Location:
Boston, MA
Job Type:
Full-Time
Permanent
Occupation:
Regulatory Affairs Managers
Career Level / Education:
High school diploma or equivalent
Salary:
Six Figure Jobs (more than $100K)
Certifications / Licenses:
N/A
Workkeys
Applied Math
4
Graphic Literacy
4
Workplace Documents
5
apply
Detailed Job Information

Senior Director, DMPK

Vertex Pharmaceuticals
San Diego, CA
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Job Description Vertex San Diego Drug Metabolism and Pharmacokinetics (DMPK) ...
Details
Summary
About the job:
team is seeking a highly motivated, experienced scientist and leader Senior Director level to help advance discovery and development of transformational therapies for serious unmet medical needs. The Senior Director of Drug Metabolism & Pharmacokinetics will be part of the global DMPK and local site leadership teams. This role's responsibilities include developing and maintaining optimal organization within DMPK, as well as the scientific and managerial coordination of its groups and personnel. This role will...
Location:
San Diego, CA
Job Type:
Full-Time
Permanent
Occupation:
Regulatory Affairs Managers
Career Level / Education:
Bachelor's degree
Salary:
Six Figure Jobs (more than $100K)
Certifications / Licenses:
N/A
Workkeys
Applied Math
6
Graphic Literacy
4
Workplace Documents
5
apply
Detailed Job Information
1

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Occupation: Regulatory Affairs Managers
Company Name: Vertex Pharmaceuticals
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