Manager of Regulatory Affairs Jobs in Newton, 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.
Manager, Regulatory Affairs (Ophthalmic Laser)
- Boston, MA (6 miles from Newton, MA)
- 1 day ago
- Boston, MA (6 miles from Newton, MA)
- 1 day ago
Bausch + Lomb (NYSE/TSX: BLCO) is a leading global eye health company dedicated to protecting and enhancing the gift of sight for millions of people around the worldfrom the moment of birth...
- Somerville, MA (4 miles from Newton, MA)
- 2 days ago
- Somerville, MA (4 miles from Newton, MA)
- 2 days ago
Find the job made for you. Browse over 130K jobs at top companies and fast-growing startups. Create an account Sign up with Google or Sign up with Email Full Name Email Password By continuing you...
Senior Director, Regulatory Affairs Advertising & Promotion (Remote)
- Boston, MA (6 miles from Newton, MA)
- 3 days ago
- Boston, MA (6 miles from Newton, MA)
- 3 days ago
Job Description General Summary: The Senior Director, Global Regulatory Affairs Advertising Promotion is responsible for providing commercial regulatory strategy and oversight in the development,...
Regulatory Affairs and Compliance Manager, Part-time
- Burlington, MA (10 miles from Newton, MA)
- 5 days ago
- Burlington, MA (10 miles from Newton, MA)
- 5 days ago
system requirements for medical devices are effectively established and maintained in accordance with 21 CFR 820, ISO 13485, 21 CFR Part 11, IEC 62304 and other regulations and guidelines as applicable...
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Associate Director, Regulatory Affairs (mRNA vaccines)
- Waltham, MA (4 miles from Newton, MA)
- 7 days ago
- Waltham, MA (4 miles from Newton, MA)
- 7 days ago
Site Name: USA - Pennsylvania - Upper Providence, Cambridge Park Drive, Durham Blackwell Street, Rockville Vaccines, Upper Merion, Waltham Posted Date: Mar 5 2025 Are you looking for a highly...
Manager, Regulatory Affairs Strategy
- Waltham, MA (4 miles from Newton, MA)
- 7 days ago
- Waltham, MA (4 miles from Newton, MA)
- 7 days ago
Manager, Regulatory Affairs role is responsible for day-to-day regulatory activities of early/late phase investigational products, leads the writing and submission of IND/CTA/amendments and future marketing...
Senior Manager, Regulatory Affairs Advertising & Promotion
- Boston, MA (6 miles from Newton, MA)
- 8 days ago
- Boston, MA (6 miles from Newton, MA)
- 8 days ago
Overview The Senior Manager, Regulatory Affairs Advertising & Promotion will be responsible for providing strategic, operational and tactical regulatory advice to internal stakeholders regarding communications...
Remote WorkDirector, Regulatory Affairs, Specialty
- Cambridge, MA (3 miles from Newton, MA)
- 9 days ago
- Cambridge, MA (3 miles from Newton, MA)
- 9 days ago
Site Name: USA - Pennsylvania - Upper Providence, Cambridge Park Drive, Collegeville TSA, USA - Maryland - Rockville Posted Date: Mar 3 2025 Job Purpose Ensure the development of appropriate...
Associate Director, Regulatory Affairs
- Cambridge, MA (3 miles from Newton, MA)
- 10 days ago
- Cambridge, MA (3 miles from Newton, MA)
- 10 days ago
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...
Sr Director, Regulatory Affairs Advertising, Promotion & Labeling
- Cambridge, MA (3 miles from Newton, MA)
- 16 days ago
- Cambridge, MA (3 miles from Newton, MA)
- 16 days ago
Maintain current awareness of evolving FDA regulations and interpretations, FDA advisory letters, enforcement letters and policies issues affecting the pharmaceutical/biologics industry....
Remote WorkAssociate Director, Regulatory Affairs
- Waltham, MA (4 miles from Newton, MA)
- 17 days ago
- Waltham, MA (4 miles from Newton, MA)
- 17 days ago
Company Overview: Dyne Therapeutics is focused on discovering and advancing innovative life-transforming therapeutics for people living with genetically driven neuromuscular diseases. Leveraging...
Senior Manager, Regulatory Affairs, Operations
- Boston, MA (6 miles from Newton, MA)
- 20 days ago
- Boston, MA (6 miles from Newton, MA)
- 20 days ago
About the Role: We are seeking a Senior Manager, Regulatory Affairs, Operations to join our team....
Associate Director, Regulatory Affairs Vaccines CMC
- Boston, MA (6 miles from Newton, MA)
- 21 days ago
- Boston, MA (6 miles from Newton, MA)
- 21 days ago
By clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with...
Associate Director, Regulatory Affairs Vaccines CMC
- Cambridge, MA (3 miles from Newton, MA)
- 22 days ago
- Cambridge, MA (3 miles from Newton, MA)
- 22 days ago
By clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with...
Global Publishing Manager, Regulatory Affairs
- Cambridge, MA (3 miles from Newton, MA)
- 23 days ago
- Cambridge, MA (3 miles from Newton, MA)
- 23 days ago
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 WorkDemographic Data for Newton, MA
Moving to Newton, MA? Find some basic demographic data about Newton, MA below.
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Salary for Manager of Regulatory Affairs Jobs in Newton, MA
Required or preferred licenses and certifications for Manager of Regulatory Affairs positions.
Highest Education Level
Manager of Regulatory Affairss in Newton, 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
- Biology
- Immunology
- Oncology
- Assay Development
- Medical Writing
- Drug Development
- Neuroscience
- Clinical Trials
- Drug Discovery
- Biotechnology
- Infectious Disease
- Pharmacovigilance
- Medical Affairs
- Gene Therapy
- Biomarkers
- Quality Systems
- Quality Management Systems
- 21 CFR 820
- GxP
- ICH Guidelines
- ISO 13485
- Change Control
- Good Clinical Practice
- Microbiology
- Medical Device Sales
- FDA Regulations
- Document Management
- Research and Development
- Resolution
- Standard Operating Procedures
- Engineering
- Product Development
- Strategy Development
- Quality Assurance
- Implementation
- Military Background
- Auditing
- Mentoring
- Written Communication
- Verbal Communication
- Documentation
- Collaboration
- Interpersonal Skills
- Reporting
- Education Experience
- Bachelor's Degree
- English
- Regulations
- Policy Development
- Project Management
- Microsoft Office
- Microsoft Excel
- Problem Solving
- Research Skills
- Staff Supervision
- Organization
- Leadership
- Communication Skills
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