Director of Regulatory Affairs Jobs in Massachusetts
The Director of Regulatory Affairs in the quality control industry plays an essential role in ensuring that the company's products meet all regulatory standards and compliance requirements. This individual oversees the development and implementation of regulatory strategies for new and existing products, supervises the preparation of regulatory submissions, and maintains communication with regulatory authorities. They also monitor changes in regulations, interpret these updates for relevant departments within the company, and implement necessary changes to maintain compliance. They are responsible for setting the company's standards for quality, safety, and efficacy.
To excel in this role, one should possess excellent analytical skills, strategic thinking, and strong leadership abilities. A deep understanding of regulatory guidelines, ability to interpret complex regulations, and excellent communication skills are essential. They should have a degree in a relevant field, along with certifications such as Regulatory Affairs Certification (RAC), Certified Quality Auditor (CQA), and Certified Quality Engineer (CQE). Prior to becoming a Director of Regulatory Affairs, individuals might have roles such as Regulatory Affairs Specialist, Regulatory Affairs Manager, or Quality Control Manager.
Executive Director, Regulatory Affairs
- Dyne Therapeutics, Inc.
- Waltham, MA
- 6 days ago
- Waltham, MA
- 6 days ago
Role Summary: The Executive Director, Regulatory Affairs serves as a visionary leader who shapes long-term program regulatory strategy, collaborates on regulatory functional strategy, and drives organizational...
In PersonThis role leads the planning, preparation, and submission of regulatory filings (e.g., Pre-Submissions, 510(k)s, PMAs, PMA Annual Reports, IDEs, and License Applications) and serves as a key regulatory...
In Person- ThermoFisher Scientific
- Waltham, MA
- 11 days ago
- Waltham, MA
- 11 days ago
As Director of Regulatory Affairs, you'll lead strategic initiatives to ensure regulatory compliance while driving business growth across multiple regions....
In Person- Deciphera Pharmaceuticals
- Waltham, MA
- 12 days ago
- Waltham, MA
- 12 days ago
Manager, Regulatory Affairs Deciphera Pharmaceuticals - 5.0 Waltham, MA Job Details Full-time $116,000 - $160,000 a year 2 hours ago Benefits Health insurance Dental insurance Parental leave...
In Person- Akebia Therapeutics
- Cambridge, MA
- 12 days ago
- Cambridge, MA
- 12 days ago
Director, Regulatory Affairs LinkedIn Twitter Email Message Share Regulatory Affairs Remote * ID: 25R-27 * Full-Time/Regular This position is currently based in our Cambridge, MA office....
In PersonAssociate Regulatory Affairs Director, Spine
- IQVIA Holdings Inc
- Washington, MA
- 14 days ago
- Washington, MA
- 14 days ago
Overview The Associate Director, Regulatory Affairs, Spine will be a critical team member supporting regulatory strategy and submissions for the firm's clientele....
In PersonDirector, Regulatory Affairs - Regenerative Medicine & Biologics Quality
- IQVIA Holdings Inc
- Washington, MA
- 15 days ago
- Washington, MA
- 15 days ago
Overview The Director, Regulatory Affairs will be a critical team member supporting regulatory strategy and submissions for the firm's clientele....
In Person- Monte Rosa Therapeutics Inc.
- Boston, MA
- 23 days ago
- Boston, MA
- 23 days ago
Overview Responsible for the coordination and preparation of document packages for regulatory submissions ensuring compliance with the Food and Drug Administration (FDA) and international...
In PersonJobs Worcester, MA Director, Regulatory Affairs Bausch + Lomb Director, Regulatory Affairs Worcester, MA Apply Bausch + Lomb (NYSE/TSX: BLCO) is a leading global eye health company dedicated to protecting...
In PersonAssociate Director, Regulatory Affairs Advertising and Promotion
- Recordati S.p.A
- Bridgewater, MA
- 29 days ago
- Bridgewater, MA
- 29 days ago
Reporting Structure Reports To: Director, Regulatory Affairs - Advertising, Promotion, and Labeling Direct Report(s): None Areas Managed: Advertising & Promotion North America Overview This role is...
In PersonSenior Manager, Regulatory Affairs Advertising and Promotion
- Sanofi
- Cambridge, MA
- 30+ days ago
- Cambridge, MA
- 30+ days ago
Job Title: Senior Manager, Regulatory Affairs Advertising and Promotion Location: Morristown, NJ/Cambridge, MA About the Job As the Senior Manager, Regulatory Affairs Advertising and Promotion...
In PersonSr. Manager, Regulatory Affairs, CMC
- Alnylam Pharmaceuticals, Inc.
- Cambridge, MA
- 30+ days ago
- Cambridge, MA
- 30+ days ago
This position reports to the Director of Regulatory Affairs CMC, or equivalent. This position is hybrid and will be primarily located in Cambridge, MA....
HybridAssociate Director, Regulatory Affairs
- Entrada Therapeutics Inc.
- Boston, MA
- 45+ days ago
- Boston, MA
- 45+ days ago
The Organization What's happening at Entrada Therapeutics? Entrada is a clinical-stage biopharmaceutical company aiming to transform the lives of patients by establishing a new class of medicines...
RemoteThis role leads the planning, preparation, and submission of regulatory filings (e.g., Pre-Submissions, 510(k)s, PMAs, PMA Annual Reports, IDEs, and License Applications) and serves as a key regulatory...
In PersonJob Title: Manager Regulatory Affairs Location: Morristown, NJ Cambridge, MA About the Job Join the engine of Sanofi's mission - where deep immunoscience meets bold, AI-powered research. In R&D,...
In PersonDemographic Data for Massachusetts
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Required or preferred licenses and certifications for Director of Regulatory Affairs positions.
Highest Education Level
Director of Regulatory Affairss in Massachusetts offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Director of Regulatory Affairs position
- Clinical Research
- Biology
- Virology
- Immunology
- Oncology
- Medical Writing
- Drug Development
- Neuroscience
- Biostatistics
- Clinical Trials
- Drug Discovery
- Toxicology
- Biotechnology
- Pharmacovigilance
- Medical Affairs
- Gene Therapy
- ICH GCP
- Quality Management Systems
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Microbiology
- Document Management
- Research and Development
- Medical Device Sales
- Product Launch
- FDA Regulations
- Standard Operating Procedures
- Product Development
- Analytical Skills
- Quality Assurance
- Engineering
- Strategy Development
- Auditing
- Written Communication
- Process Improvement
- Documentation
- Coaching
- Mentoring
- Interpersonal Skills
- Writing Skills
- Implementation
- Verbal Communication
- Reporting
- Education Experience
- Collaboration
- Bachelor's Degree
- Regulations
- Research Skills
- Project Management
- Problem Solving
- Staff Supervision
- Scheduling
- Teamwork
- Leadership
- Communication Skills
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