Manager of Regulatory Affairs Jobs in Somerville, MA
Associate Director, Regulatory Affairs CMC
- Cambridge, MA (1 mile from Somerville, MA)
- 19 hours ago
- Cambridge, MA (1 mile from Somerville, MA)
- 19 hours ago
Why Join Intellia? Our mission is to develop curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases. Beyond our...
Associate Regulatory Affairs Director
- Boston, MA (2 miles from Somerville, MA)
- 19 hours ago
- Boston, MA (2 miles from Somerville, MA)
- 19 hours ago
Associate Regulatory Affairs Director Introduction to role The Associate Regulatory Affairs Director (ARAD) is an experienced regulatory specialist with strong project management capabilities...
Director, Regulatory Affairs, Advertising and Promotion
- Bedford, MA (12 miles from Somerville, MA)
- 2 days ago
- Bedford, MA (12 miles from Somerville, MA)
- 2 days ago
Act as a subject matter expert on FDA regulations, guidance, enforcement trends and policy issues relevant to promotion and labeling....
Director, Regulatory Affairs, Specialty
- Cambridge, MA (1 mile from Somerville, MA)
- 2 days ago
- Cambridge, MA (1 mile from Somerville, MA)
- 2 days ago
Site Name: USA - Pennsylvania - Upper Providence, Cambridge Park Drive, Collegeville TSA, USA - Maryland - Rockville Posted Date: Apr 29 2025 Job Purpose Ensure the development of appropriate...
Senior Manager, Regulatory Affairs
- Salem, MA (13 miles from Somerville, MA)
- 3 days ago
- Salem, MA (13 miles from Somerville, MA)
- 3 days ago
Job Overview We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Senior Manager, Regulatory Affairs....
Sr Director, Regulatory Affairs Advertising, Promotion & Labeling
- Cambridge, MA (1 mile from Somerville, MA)
- 5 days ago
- Cambridge, MA (1 mile from Somerville, MA)
- 5 days ago
Maintain current awareness of evolving FDA regulations and interpretations, FDA advisory letters, enforcement letters and policies issues affecting the pharmaceutical/biologics industry....
Remote Work- Cambridge, MA (1 mile from Somerville, MA)
- 6 days ago
- Cambridge, MA (1 mile from Somerville, MA)
- 6 days ago
Director, Regulatory Affairs Cambridge, MA | On-site An innovative biotech company based in Cambridge is seeking a Director of Regulatory Affairs to serve as the organization's first regulatory...
Director, Regulatory Affairs Strategy
- Boston, MA (2 miles from Somerville, MA)
- 8 days ago
- Boston, MA (2 miles from Somerville, MA)
- 8 days ago
Location: REMOTE Salary: $190,000.00 USD Annually - $215,000.00 USD Annually Description: Our client is currently seeking a Director, Regulatory Affairs Strategy who will be responsible for...
Quality Systems & Regulatory Affairs Manager
- Boston, MA (2 miles from Somerville, MA)
- 9 days ago
- Boston, MA (2 miles from Somerville, MA)
- 9 days ago
management and regulatory strategy within WHOOP Support development and maintenance of WHOOPs FDA-compliant QMS, ensuring adherence to 21 CFR 820 and ISO 13485:2016 Coordinate and lead internal audits...
- Wellesley Hills, MA (10 miles from Somerville, MA)
- 9 days ago
- Wellesley Hills, MA (10 miles from Somerville, MA)
- 9 days ago
Manager, Regulatory Affairs based at our corporate headquarters in Wellesley, MA....
Associate Director, Regulatory Affairs CMC
- Cambridge, MA (1 mile from Somerville, MA)
- 14 days ago
- Cambridge, MA (1 mile from Somerville, MA)
- 14 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...
Senior Manager, Regulatory Affairs (Clinical)
- Boston, MA (2 miles from Somerville, MA)
- 16 days ago
- Boston, MA (2 miles from Somerville, MA)
- 16 days ago
About the Role: We are seeking a Senior Manager, Regulatory Affairs to join our team....
Senior Manager, Regulatory Affairs
- Waltham, MA (8 miles from Somerville, MA)
- 17 days ago
- Waltham, MA (8 miles from Somerville, MA)
- 17 days ago
The Senior Manager, Regulatory Operations will report to the Executive Director of Regulatory Operations and will be responsible for submission management across the development pipeline and...
Senior Manager, Regulatory Affairs
- Cambridge, MA (1 mile from Somerville, MA)
- 18 days ago
- Cambridge, MA (1 mile from Somerville, MA)
- 18 days ago
RAC certification recommended Proficiency with Microsoft Office Applications; Word, Excel, Outlook, Adobe, and regulatory/quality systems. What Now?...
Senior Manager, Regulatory Affairs
- Waltham, MA (8 miles from Somerville, MA)
- 20 days ago
- Waltham, MA (8 miles from Somerville, MA)
- 20 days ago
Company Description Position Summary: The Senior Manager, Regulatory Affairs provides regulatory support for oncology products in early- and late-stage development....
Demographic Data for Somerville, MA
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Salary for Manager of Regulatory Affairs Jobs in Somerville, MA
Required or preferred licenses and certifications for Manager of Regulatory Affairs positions.
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Manager 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 Manager of Regulatory Affairs position
- Biomarkers
- Gene Therapy
- Next-Generation Sequencing
- Drug Discovery
- 21 CFR 820
- Internal Audits
- Pharmacovigilance
- Assay Development
- ICH Guidelines
- Drug Development
- Immunology
- Change Control
- Quality Management Systems
- Quality Systems
- ISO 13485
- Biotechnology
- Neurology
- Oncology
- Medical Device Sales
- Clinical Trials
- Document Management
- Biology
- FDA Regulations
- Research and Development
- Clinical Research
- Resolution
- Standard Operating Procedures
- Product Development
- Medical Terminology
- Strategy Development
- Engineering
- Implementation
- Written Communication
- Military Background
- Verbal Communication
- Investigation
- Collaboration
- Documentation
- Interpersonal Skills
- Mentoring
- Quality Assurance
- Reporting
- Coaching
- Education Experience
- Bachelor's Degree
- Regulations
- Problem Solving
- Policy Development
- Project Management
- Microsoft Excel
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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