Manager of Regulatory Affairs Jobs in Burlington, MA
A Manager of Regulatory Affairs in the quality control industry plays a pivotal role in ensuring that the company's products meet all necessary regulatory standards. Their key responsibilities include developing and implementing regulatory strategies, monitoring changes to regulatory guidelines, and ensuring the organization's compliance with these changes. They also engage in the preparation, review, and submission of regulatory documents to regulatory agencies. To effectively execute these responsibilities, they liaise with various stakeholders within and outside the organization, such as product developers, project managers, and regulatory bodies.
Important skills and certifications for a Manager of Regulatory Affairs include strong organizational and project management skills, excellent written and verbal communication skills, as well as a keen eye for detail. Analytical thinking and problem-solving skills are also crucial in this role. Additionally, they should possess relevant certifications such as the Regulatory Affairs Certification (RAC), which is recognized worldwide as the leading credential for regulatory professionals in the healthcare product sector. Before becoming a Manager of Regulatory Affairs, a person may have roles such as a Regulatory Affairs Specialist, Quality Control Analyst, or a Quality Assurance Associate. These roles would provide the necessary exposure and experience in quality control and regulatory affairs needed for the managerial position.
Director, Regulatory Affairs, Regulatory Science & Execution
- Boston, MA (12 miles from Burlington, MA)
- 1 day ago
- Boston, MA (12 miles from Burlington, MA)
- 1 day ago
This is what you will do: The Regulatory Affairs Director (RAD), Regulatory Science & Execution will be accountable for the develop ment, implement ation and maintenance of regulatory strategies...
- Acton, MA (11 miles from Burlington, MA)
- 3 days ago
- Acton, MA (11 miles from Burlington, MA)
- 3 days ago
Job Title: Director, Regulatory Affairs Department: Regulatory Affairs and Compliance Manager/Supervisor: Sr. Director, Regulatory Affairs FLSA Status: Exempt Position Overview: This position is...
Senior Manager, Regulatory Affairs CMC (Hybrid Onsite)
- Waltham, MA (8 miles from Burlington, MA)
- 7 days ago
- Waltham, MA (8 miles from Burlington, MA)
- 7 days ago
Job Description The Senior Manager Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) works with internal and external partners to deliver products to patients....
Associate Director/Director, Regulatory Affairs
- Boston, MA (12 miles from Burlington, MA)
- 9 days ago
- Boston, MA (12 miles from Burlington, MA)
- 9 days ago
Seaport Therapeutics is a clinical-stage biopharmaceutical company advancing the development of novel neuropsychiatric medicines in areas of high unmet patient needs. The Company has a proven...
Director, Regulatory Affairs - Labeling
- Boston, MA (12 miles from Burlington, MA)
- 9 days ago
- Boston, MA (12 miles from Burlington, MA)
- 9 days ago
About the Role >>> Director, Regulatory Labeling As the Director, Regulatory Labeling, reporting to the Vice President, Regulatory Affairs and Quality Assurance you will lead the development of...
Director, Regulatory Affairs - Specialty Medicine
- Cambridge, MA (9 miles from Burlington, MA)
- 16 days ago
- Cambridge, MA (9 miles from Burlington, MA)
- 16 days ago
Site Name: USA - Pennsylvania - Upper Providence, Cambridge MA, USA - North Carolina - Durham Posted Date: Jul 15 2025 Director, Regulatory Affairs - Specialty Medicine Join GSK as a Regulatory...
Senior Manager, Regulatory Affairs, Operations
- Boston, MA (12 miles from Burlington, MA)
- 18 days ago
- Boston, MA (12 miles from Burlington, MA)
- 18 days ago
About the Role: We are seeking a Senior Manager, Regulatory Affairs, Operations to join our team....
Pioneering Medicines: Senior Director, Regulatory Affairs
- Cambridge, MA (9 miles from Burlington, MA)
- 22 days ago
- Cambridge, MA (9 miles from Burlington, MA)
- 22 days ago
What if... We could harness the power of Flagship's scientific platforms and create novel treatment options that benefit more patients, sooner? Pioneering Medicines, an initiative of Flagship...
Regulatory Affairs Director, Global Regulatory Strategy
- Boston, MA (12 miles from Burlington, MA)
- 23 days ago
- Boston, MA (12 miles from Burlington, MA)
- 23 days ago
Position Summary: The Regulatory Affairs Director (RAD), Global Regulatory Strategy will be responsible for the development and implementation of global regulatory strategies for all assigned...
Associate Director/Director of Regulatory Affairs
- Boston, MA (12 miles from Burlington, MA)
- 25 days ago
- Boston, MA (12 miles from Burlington, MA)
- 25 days ago
Associate Director/Director of Regulatory Affairs Location Boston Discipline: Regulatory Affairs Job type: Permanent Salary: DOE Contact name: Josh Swistak Contact email: ... Contact phone: +......
- Cambridge, MA (9 miles from Burlington, MA)
- 29 days ago
- Cambridge, MA (9 miles from Burlington, MA)
- 29 days ago
regulations; ICH guidelines; Leading cross-functional product development teams....
Director of Regulatory Affairs
- Watertown, MA (9 miles from Burlington, MA)
- 30+ days ago
- Watertown, MA (9 miles from Burlington, MA)
- 30+ days ago
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...
Senior Director Regulatory Affairs, Sports Medicine & ENT
- Andover, MA (10 miles from Burlington, MA)
- 30+ days ago
- Andover, MA (10 miles from Burlington, MA)
- 30+ days ago
In-depth knowledge of FDA regulations, EU MDR, ISO 13485, and other international regulatory standards....
Associate Director, Regulatory Affairs
- Boston, MA (12 miles from Burlington, MA)
- 30+ days ago
- Boston, MA (12 miles from Burlington, MA)
- 30+ days ago
regulations, particularly 21 CFR 1271 and 21 CFR 312....
Executive Director, Regulatory Affairs - Cell Medicine
- Cambridge, MA (9 miles from Burlington, MA)
- 45+ days ago
- Cambridge, MA (9 miles from Burlington, MA)
- 45+ days ago
In this key leadership role, you will build and oversee Global Regulatory Science and Regulatory CMC strategic framework and will support driving deliverables for the Regeneron Cell Medicines,...
Demographic Data for Burlington, MA
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Salary for Manager of Regulatory Affairs Jobs in Burlington, MA
Required or preferred licenses and certifications for Manager of Regulatory Affairs positions.
Highest Education Level
Manager of Regulatory Affairss in Burlington, 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
- Clinical Research
- Biochemistry
- Biology
- Immunology
- Scientific Writing
- Drug Development
- Clinical Trials
- Biotechnology
- Pharmacovigilance
- Medical Affairs
- Masters In Education
- Gene Therapy
- Internal Audits
- Quality Systems
- Supplier Auditing
- Quality Management Systems
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Change Control
- GxP
- Microbiology
- Product Launch
- Document Management
- Medical Device Sales
- Research and Development
- FDA Regulations
- Standard Operating Procedures
- Product Development
- Engineering
- Strategy Development
- Quality Assurance
- Auditing
- Military Background
- Implementation
- Written Communication
- Education Experience
- Mentoring
- Verbal Communication
- Documentation
- Employee Development
- Reporting
- Coaching
- Collaboration
- Interpersonal Skills
- Filing
- Bachelor's Degree
- Policy Development
- Regulations
- Project Management
- Problem Solving
- Research Skills
- Time Management
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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