Director of Regulatory Affairs Jobs in Woburn, MA
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 (8 miles from Woburn, MA)
- 6 days ago
- Waltham, MA (8 miles from Woburn, 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 PersonDirect Hire SR Manager Regulatory Affairs
- Adecco
- Andover, MA (11 miles from Woburn, MA)
- 11 days ago
- Andover, MA (11 miles from Woburn, MA)
- 11 days ago
This 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 (8 miles from Woburn, MA)
- 11 days ago
- Waltham, MA (8 miles from Woburn, 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 (8 miles from Woburn, MA)
- 12 days ago
- Waltham, MA (8 miles from Woburn, 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 (7 miles from Woburn, MA)
- 13 days ago
- Cambridge, MA (7 miles from Woburn, MA)
- 13 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 Person- Monte Rosa Therapeutics Inc.
- Boston, MA (10 miles from Woburn, MA)
- 23 days ago
- Boston, MA (10 miles from Woburn, 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 Person- Bausch + Lomb
- Natick, MA (17 miles from Woburn, MA)
- 24 days ago
- Natick, MA (17 miles from Woburn, MA)
- 24 days ago
Jobs Natick, MA Director, Regulatory Affairs Bausch + Lomb Director, Regulatory Affairs Natick, MA Apply Bausch + Lomb (NYSE/TSX: BLCO) is a leading global eye health company dedicated to protecting...
In PersonSenior Manager, Regulatory Affairs Advertising and Promotion
- Sanofi
- Cambridge, MA (7 miles from Woburn, MA)
- 30+ days ago
- Cambridge, MA (7 miles from Woburn, 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 (7 miles from Woburn, MA)
- 30+ days ago
- Cambridge, MA (7 miles from Woburn, 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 (10 miles from Woburn, MA)
- 45+ days ago
- Boston, MA (10 miles from Woburn, 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...
RemoteSenior Manager, Regulatory Affairs NAM
- Straumann
- Andover, MA (11 miles from Woburn, MA)
- 45+ days ago
- Andover, MA (11 miles from Woburn, MA)
- 45+ days ago
This 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- Sanofi
- Cambridge, MA (7 miles from Woburn, MA)
- 45+ days ago
- Cambridge, MA (7 miles from Woburn, MA)
- 45+ days ago
Job 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 PersonDirector, Regulatory Affairs, Advertising and Promotion
- Alkermes
- Waltham, MA (8 miles from Woburn, MA)
- 60+ days ago
- Waltham, MA (8 miles from Woburn, MA)
- 60+ days ago
Reporting to the Vice President, Regulatory Affairs, Advertising, Promotion & Labeling, the Director, Regulatory Affairs, Advertising and Promotion will be responsible for providing sound regulatory...
HybridSenior Director, Regulatory Affairs
- Verastem, Inc.
- Boston, MA (10 miles from Woburn, MA)
- 60+ days ago
- Boston, MA (10 miles from Woburn, MA)
- 60+ days ago
The Senior Director, Regulatory Affair has experience in the pharmaceutical industry and an outstanding working understanding of the U.S. regulatory environment....
HybridAssociate Director Regulatory Affairs Vascular (on-site)
- Abbott
- Westford, MA (15 miles from Woburn, MA)
- 90+ days ago
- Westford, MA (15 miles from Woburn, MA)
- 90+ days ago
The Opportunity This Associate Director, Regulatory Affairs will work on-site at our Westford, MA location in the Vascular Division....
In PersonDemographic Data for Woburn, MA
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Director of Regulatory Affairss in Woburn, 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
- 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
- Good Laboratory Practice
- ISO 13485
- Microbiology
- Document Management
- Research and Development
- Medical Device Sales
- FDA Regulations
- Standard Operating Procedures
- Product Development
- Analytical Skills
- Quality Assurance
- Engineering
- Strategy Development
- Auditing
- Process Improvement
- Documentation
- Coaching
- Mentoring
- Interpersonal Skills
- Writing Skills
- Implementation
- Verbal Communication
- Reporting
- Education Experience
- Collaboration
- Bachelor's Degree
- Regulations
- Research Skills
- Microsoft Office
- Project Management
- Problem Solving
- Staff Supervision
- Scheduling
- Teamwork
- Leadership
- Communication Skills
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