Manager of Regulatory Affairs Jobs in Massachusetts
Experience in maintenance of IND and NDA submissions with a thorough understanding of FDA regulations, ICH guidelines, and post approval labeling and CMC change requirements....
Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing...
Position Overview: Astria Therapeutics is dedicated to bringing hope with life-changing therapies to patients and families affected by allergic and immunological diseases. Astria's pipeline...
Job Listing ID: 4346559 Job Title: Director, Regulatory Affairs Application Deadline: Open Until FilledJob Location: Salem Date Posted: 09/10/2025Hours Worked Per Week: Not Provided Shift: Not...
Experience with combination products (e.g., inhaled, injectable, or wearable systems) and an understanding of applicable FDA regulations and guidance (e.g. Human Factors, bridging strategies)....
Director, Regulatory Affairs, Global Regulatory Strategy
- Bedford, MA
- 6 days ago
- Bedford, MA
- 6 days ago
About Stoke: Stoke Therapeutics (Nasdaq: STOK) is a biotechnology company dedicated to restoring protein expression by harnessing the body's potential with RNA medicine. Stoke is developing...
At Corner Therapeutics, Inc, our mission is to transform the standard of care, ushering in a new era of robust, rapid, patient-friendly and low-cost immunotherapies - even for the most difficult...
Return to selected search result Director, Regulatory Affairs Apply locations Massachusetts Canada United States time type Full time posted on Posted Today job requisition id R-202507607 Job...
Remote WorkWe are seeking an individual who is talented, motivated, and passionate about science to join our Regulatory Strategy team. As a Director of Regulatory Affairs, the successful candidate will play...
Reporting to the Vice President, Regulatory Affairs, Advertising Promotion & Labeling, the Director, Regulatory Affairs, Labeling will lead and facilitate the generation of new, and revision of,...
Working knowledge of global regulatory systems, including EU MDR, ISO 13485, and CPSC regulations....
Are you ready to join a team committed to making a meaningful impact on cancer treatment through the discovery and development of precision medicines? At Kura Oncology, you have an opportunity to...
Job Listing ID: 4329444 Job Title: Regulatory Affairs Director (US) Application Deadline: Open Until FilledJob Location: Salem Date Posted: 08/14/2025Hours Worked Per Week: Not Provided Shift: Not...
Director Regulatory Affairs I Titleist Acushnet Golf - 3.9 New Bedford, MA Job Details Full-time $147,498 - $191,778 a year 1 hour ago Benefits Health savings account Flexible spending account...
Where Performance Meets Purpose Join a team that values excellence and innovation, at a company known for its iconic golf brands. At Acushnet Company, your background and experience contribute to...
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Manager of Regulatory Affairss in Massachusetts offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Manager of Regulatory Affairs position
- Gene Therapy
- Medical Affairs
- ICH Guidelines
- 21 CFR 820
- Pharmacovigilance
- Quality Systems
- ISO 13485
- Medical Writing
- Drug Development
- GxP
- Immunology
- Change Control
- Toxicology
- Biotechnology
- Quality Management Systems
- Biology
- Microbiology
- Oncology
- Medical Device Sales
- Document Management
- Clinical Trials
- Product Launch
- Good Manufacturing Practices
- Clinical Research
- Research and Development
- FDA Regulations
- Resolution
- Standard Operating Procedures
- Product Development
- Strategy Development
- Engineering
- Implementation
- Written Communication
- Military Background
- Analytical Skills
- Auditing
- Verbal Communication
- Collaboration
- Documentation
- Coaching
- Reporting
- Mentoring
- Interpersonal Skills
- Education Experience
- Quality Assurance
- Policy Development
- Filing
- Problem Solving
- Bachelor's Degree
- Project Management
- Regulations
- Microsoft Office
- Research Skills
- Staff Supervision
- Organization
- Teamwork
- Scheduling
- Leadership
- Communication Skills
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