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.
Senior Manager, Regulatory Affairs
- Cambridge, MA (9 miles from Burlington, MA)
- 11 hours ago
- Cambridge, MA (9 miles from Burlington, MA)
- 11 hours ago
Senior Manager, Regulatory Affairs Primary Work Location Remote - US or Hybrid - Cambridge, MA Job Code 2307 # of openings 1 Senior Manager, Regulatory Affairs Strategy Who we are: Agios is a biopharmaceutical...
Associate Director, Regulatory Affairs Strategy
- Cambridge, MA (9 miles from Burlington, MA)
- 14 hours ago
- Cambridge, MA (9 miles from Burlington, MA)
- 14 hours ago
Associate Director, Regulatory Affairs Strategy Who we are: Agios is a biopharmaceutical company that is fueled by connections. We thrive in a supportive, fun, and flexible environment full of...
Assoc Dir/Director, Regulatory Affairs
- Boston, MA (12 miles from Burlington, MA)
- 3 days ago
- Boston, MA (12 miles from Burlington, MA)
- 3 days ago
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...
Executive Director, Regulatory Affairs & Quality Assurance.
- Waltham, MA (8 miles from Burlington, MA)
- 10 days ago
- Waltham, MA (8 miles from Burlington, MA)
- 10 days ago
Assure all supplier quality systems are consistent with worldwide quality and regulatory requirements....
Manager, Regulatory Affairs (IVD On-Market/Sustaining)
- Marlborough, MA (20 miles from Burlington, MA)
- 11 days ago
- Marlborough, MA (20 miles from Burlington, MA)
- 11 days ago
Manager, Regulatory Affairs (IVD On-Market/Sustaining) San Diego, CA, United States Marlborough, MA, United States We are hiring in our Diagnostics Regulatory Affairs team based out of our San Diego...
Director, Regulatory Affairs, Regulatory Science & Execution
- Boston, MA (12 miles from Burlington, MA)
- 15 days ago
- Boston, MA (12 miles from Burlington, MA)
- 15 days ago
This is what you will do: The Regulatory Affairs Director (RAD), Regulatory Science & Execution will be accountable for the development, implementation and maintenance of regulatory strategies for...
Senior Manager of Regulatory Affairs
- Woburn, MA (2 miles from Burlington, MA)
- 23 days ago
- Woburn, MA (2 miles from Burlington, MA)
- 23 days ago
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...
Sr. Director, Regulatory Affairs - CMC
- Cambridge, MA (9 miles from Burlington, MA)
- 30+ days ago
- Cambridge, MA (9 miles from Burlington, MA)
- 30+ days ago
Sr. Director, Regulatory Affairs - CMC CMC / Technical Operations Cambridge, MA ID: 25R-19 Full-Time/Regular Nearly 37 million Americans are currently affected by Chronic Kidney Disease. 37...
Sr. Director, Regulatory Affairs
- Cambridge, MA (9 miles from Burlington, MA)
- 30+ days ago
- Cambridge, MA (9 miles from Burlington, MA)
- 30+ days ago
Nearly 37 million Americans are currently affected by Chronic Kidney Disease. 37 million. At Akebia we take that number very seriously and every day we come to work, with the purpose of bettering...
Senior Manager, Regulatory Affairs - CMC
- Waltham, MA (8 miles from Burlington, MA)
- 30+ days ago
- Waltham, MA (8 miles from Burlington, MA)
- 30+ days ago
Company Overview: Innoviva Specialty Therapeutics, Inc., a subsidiary of Innoviva, Inc., is a biopharmaceutical company focused on developing innovative solutions for patients and healthcare...
Associate Director, Regulatory Affairs CMC
- Cambridge, MA (9 miles from Burlington, MA)
- 30+ days ago
- Cambridge, MA (9 miles from Burlington, MA)
- 30+ days 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...
Quality Systems & Regulatory Affairs Manager
- Boston, MA (12 miles from Burlington, MA)
- 45+ days ago
- Boston, MA (12 miles from Burlington, MA)
- 45+ days ago
management systems for medical device software Comprehensive knowledge of global regulatory requirements for SaMD products Strong understanding of ISO 13485 and other quality management system standards...
- Wellesley Hills, MA (14 miles from Burlington, MA)
- 45+ days ago
- Wellesley Hills, MA (14 miles from Burlington, MA)
- 45+ days ago
Manager, Regulatory Affairs based at our corporate headquarters in Wellesley, MA....
Regulatory Affairs Director, Global Regulatory Strategy
- Boston, MA (12 miles from Burlington, MA)
- 60+ days ago
- Boston, MA (12 miles from Burlington, MA)
- 60+ days ago
Position Summary: The Regulatory Affairs Director (RAD), Global Regulatory Strategy will be responsible for the development and implement ation of global regulatory strategies for all assigned...
Experience with prescription drug advertising regulations and promotional review committee's Working knowledge of FDA regulations and understanding of FDA structure and function....
Demographic Data for Burlington, MA
Moving to Burlington, MA? Find some basic demographic data about Burlington, MA below.
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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.
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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
- Assay Development
- Medical Writing
- Scientific Writing
- Drug Development
- Clinical Trials
- Toxicology
- Biotechnology
- Next-Generation Sequencing
- Pharmacovigilance
- Medical Affairs
- Gene Therapy
- ICH GCP
- Internal Audits
- Quality Management Systems
- Quality Systems
- Supplier Auditing
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- GxP
- Medical Device Sales
- Microbiology
- Document Management
- FDA Regulations
- Research and Development
- Complaint Resolution
- Resolution
- Standard Operating Procedures
- Product Development
- Engineering
- Strategy Development
- Process Improvement
- Quality Assurance
- Implementation
- Auditing
- Verbal Communication
- Written Communication
- Mentoring
- Collaboration
- Documentation
- Coaching
- Interpersonal Skills
- Reporting
- Bachelor's Degree
- Filing
- Regulations
- Policy Development
- Project Management
- Problem Solving
- Microsoft Excel
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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