Director of Regulatory Affairs Jobs in Somerville, MA
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Senior Director, Regulatory Affairs Advertising & Promotion (Remote)
- Boston, MA (2 miles from Somerville, MA)
- 1 day ago
- Boston, MA (2 miles from Somerville, MA)
- 1 day ago
Job Description General Summary: The Senior Director, Global Regulatory Affairs Advertising Promotion is responsible for providing commercial regulatory strategy and oversight in the development, review...
Regulatory Affairs and Compliance Manager, Part-time
- Burlington, MA (10 miles from Somerville, MA)
- 3 days ago
- Burlington, MA (10 miles from Somerville, MA)
- 3 days ago
system requirements for medical devices are effectively established and maintained in accordance with 21 CFR 820, ISO 13485, 21 CFR Part 11, IEC 62304 and other regulations and guidelines as applicable...
Associate Director, Regulatory Affairs (mRNA vaccines)
- Waltham, MA (8 miles from Somerville, MA)
- 5 days ago
- Waltham, MA (8 miles from Somerville, MA)
- 5 days ago
Site Name: USA - Pennsylvania - Upper Providence, Cambridge Park Drive, Durham Blackwell Street, Rockville Vaccines, Upper Merion, Waltham Posted Date: Mar 5 2025 Are you looking for a highly...
Sr. Manager, Regulatory Affairs Strategy
- Waltham, MA (8 miles from Somerville, MA)
- 5 days ago
- Waltham, MA (8 miles from Somerville, MA)
- 5 days ago
This position reports to the Director, Regulatory Affairs. Key Responsibilities: Develop and implement global regulatory strategy for assigned projects....
Senior Manager, Regulatory Affairs Advertising & Promotion
- Boston, MA (2 miles from Somerville, MA)
- 6 days ago
- Boston, MA (2 miles from Somerville, MA)
- 6 days ago
Responsibilities Serves as subject matter expert on FDA regulations and OPDP guidance governing promotion and prescription drug/ biologic products and disease awareness activities....
Remote WorkDirector, Regulatory Affairs, Specialty
- Cambridge, MA (1 mile from Somerville, MA)
- 7 days ago
- Cambridge, MA (1 mile from Somerville, MA)
- 7 days ago
Site Name: USA - Pennsylvania - Upper Providence, Cambridge Park Drive, Collegeville TSA, USA - Maryland - Rockville Posted Date: Mar 3 2025 Job Purpose Ensure the development of appropriate...
Associate Director, Regulatory Affairs
- Cambridge, MA (1 mile from Somerville, MA)
- 8 days ago
- Cambridge, MA (1 mile from Somerville, MA)
- 8 days ago
Why Sarepta? Why Now? The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold leadership positions in Duchenne muscular dystrophy (DMD) and limb-girdle muscular...
Sr Director, Regulatory Affairs Advertising, Promotion & Labeling
- Cambridge, MA (1 mile from Somerville, MA)
- 14 days ago
- Cambridge, MA (1 mile from Somerville, MA)
- 14 days ago
The Senior Director Regulatory Affairs Advertising, Promotion & Labeling (Sr. Dir....
Remote WorkAssociate Director, Regulatory Affairs
- Waltham, MA (8 miles from Somerville, MA)
- 15 days ago
- Waltham, MA (8 miles from Somerville, MA)
- 15 days ago
Role Summary: The Associate Director, Regulatory Affairs will help drive forward our regulatory strategy and operational activities related to Dyne's muscle disease programs....
Senior Manager, Regulatory Affairs, Operations
- Boston, MA (2 miles from Somerville, MA)
- 18 days ago
- Boston, MA (2 miles from Somerville, MA)
- 18 days ago
This position reports to the Director, Regulatory Affairs, Operations and will be in Boston, MA, USA. We will consider other jurisdictions for exceptional candidates....
Associate Director, Regulatory Affairs Vaccines CMC
- Boston, MA (2 miles from Somerville, MA)
- 19 days ago
- Boston, MA (2 miles from Somerville, MA)
- 19 days ago
By clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with...
Associate Director, Regulatory Affairs Vaccines CMC
- Cambridge, MA (1 mile from Somerville, MA)
- 20 days ago
- Cambridge, MA (1 mile from Somerville, MA)
- 20 days ago
By clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with...
Global Publishing Manager, Regulatory Affairs
- Cambridge, MA (1 mile from Somerville, MA)
- 21 days ago
- Cambridge, MA (1 mile from Somerville, MA)
- 21 days ago
The Role The Regulatory Operations Global Publishing Manager is responsible for overseeing the planning, creation, and submission of regulatory submissions. In collaboration with the Regulatory...
Remote WorkMgr, Regulatory Affairs Pharma - HealthCanada
- Waltham, MA (8 miles from Somerville, MA)
- 23 days ago
- Waltham, MA (8 miles from Somerville, MA)
- 23 days ago
This is a fully remote position. This person should be a subject matter expert on Regulatory Affairs as it relates to HealthCanada. Provides regulatory input to facilitate the timely preparation...
Remote WorkDemographic Data for Somerville, MA
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Director of Regulatory Affairss in Somerville, MA offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Director of Regulatory Affairs position
- Biomarkers
- Drug Discovery
- Pharmacovigilance
- Medical Writing
- Medical Affairs
- 21 CFR 820
- GxP
- Assay Development
- ICH Guidelines
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- Quality Systems
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- Infectious Disease
- ISO 13485
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- FDA Regulations
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- Military Background
- Written Communication
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- Auditing
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- Interpersonal Skills
- Quality Assurance
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- English
- Education Experience
- Bachelor's Degree
- Regulations
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- Microsoft Excel
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- Gene Therapy
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