Manager of Regulatory Affairs Jobs in Massachusetts
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.
The Role The Regulatory Operations Global Publishing Manager is responsible for overseeing the planning, creation, and submission of regulatory submissions. In collaboration with the Regulatory...
Remote Workcompliance.Provide guidance and insight to senior management on regulatory trends, risks, and opportunities impacting the organization.Ensure compliance with global regulatory requirements, including FDA...
Why Sarepta? Why Now? The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold leadership positions in Duchenne muscular dystrophy (DMD) and limb-girdle muscular...
About the Role: We are seeking a Senior Manager, Regulatory Affairs to join our team....
The Senior Manager, Regulatory Operations will report to the Executive Director of Regulatory Operations and will be responsible for submission management across the development pipeline and...
RAC certification recommended Proficiency with Microsoft Office Applications; Word, Excel, Outlook, Adobe, and regulatory/quality systems. What Now?...
Director of Regulatory Affairs Operations, Ultrasound** The Director of Regulatory Affairs Operations for the Ultrasound business will be responsible for leading a global Regulatory Affairs team...
system and regulatory product compliance requirements; e.g 21 CFR 820, ISO 13485/9001, QMSR, EU MDR, ISO 14971, UL, CSA, NSF, NMPA, Health Canada We provide competitive salary, an annual incentive...
Company Description Position Summary: The Senior Manager, Regulatory Affairs provides regulatory support for oncology products in early- and late-stage development....
Associate Regulatory Affairs Director Introduction to role The Associate Regulatory Affairs Director (ARAD) is an experienced regulatory specialist with strong project management capabilities...
A fast-growing oncology business seeks an Executive Director of Regulatory Affairs to lead a remote US hematology team. This role involves managing senior regulatory leaders responsible for...
Senior Director, Regulatory Affairs Regulatory - Waltham, Massachusetts Visterra is seeking a Regulatory Affairs professional experienced in biologics development to lead our Regulatory Team's...
Regulatory Affairs Director, Global Regulatory Strategy
- Boston, MA
- 12 days ago
- Boston, MA
- 12 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...
POSTED Apr 4, 2025 Description SUMMARY The Senior Manager of Regulatory Affairs will lead the regulatory compliance and labeling function, ensuring that products comply with all applicable regulations...
Why Sarepta? Why Now? The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold leadership positions in Duchenne muscular dystrophy (DMD) and limb-girdle muscular...
Demographic Data for Massachusetts
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Salary for Manager of Regulatory Affairs Jobs in Massachusetts
Required or preferred licenses and certifications for Manager of Regulatory Affairs positions.
Highest Education Level
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
- Clinical Research
- Bioinformatics
- Biology
- Immunology
- Medical Writing
- Drug Development
- Clinical Trials
- Drug Discovery
- Biotechnology
- Pharmacovigilance
- Medical Affairs
- Gene Therapy
- Biomarkers
- Internal Audits
- Quality Management Systems
- Quality Systems
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Change Control
- Good Clinical Practice
- Microbiology
- Medical Device Sales
- FDA Regulations
- Document Management
- Research and Development
- Resolution
- Standard Operating Procedures
- Product Development
- Engineering
- Affirmative Action
- Risk Management
- Strategy Development
- Quality Assurance
- Process Improvement
- Implementation
- Auditing
- Written Communication
- Verbal Communication
- Strategic Planning
- Documentation
- Mentoring
- Collaboration
- Reporting
- Education Experience
- Interpersonal Skills
- Coaching
- Bachelor's Degree
- Regulations
- Policy Development
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Teamwork
- Staff Supervision
- Organization
- Research Skills
- Leadership
- Communication Skills
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