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.
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
- 5 days ago
- Waltham, MA
- 5 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....
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...
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
- 14 days ago
- Cambridge, MA
- 14 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...
About the Role: We are seeking a Senior Manager, Regulatory Affairs, Operations to join our team....
You have extensive experience/knowledge of global medical device regulations, requirements, and standards (ISO 13485, ISO 14971, 21 CFR 820, etc.)...
Pioneering Medicines: Senior Director, Regulatory Affairs
- Cambridge, MA
- 20 days ago
- Cambridge, MA
- 20 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...
Visterra is seeking a Regulatory Affairs professional experienced in biologics development to lead our Regulatory Team's strategy and oversee the teams activities from IND-enabling studies and...
Regulatory Affairs Director, Global Regulatory Strategy
- Boston, MA
- 21 days ago
- Boston, MA
- 21 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...
With its beginnings in a family run pharmacy in Correggio, Italy in the 1920s, Recordati is now a global pharmaceutical company, listed on the Italian stock exchange, with over 4,500 employees and...
Associate Director/Director of Regulatory Affairs Location Boston Discipline: Regulatory Affairs Job type: Permanent Salary: DOE Contact name: Josh Swistak Contact email: ... Contact phone: +......
regulations; ICH guidelines; Leading cross-functional product development teams....
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
- 30+ days ago
- Andover, MA
- 30+ days ago
In-depth knowledge of FDA regulations, EU MDR, ISO 13485, and other international regulatory standards....
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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
- Biochemistry
- Biology
- Immunology
- Medical Writing
- 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
- Medical Device Sales
- Product Launch
- Document Management
- Research and Development
- FDA Regulations
- Standard Operating Procedures
- Product Development
- Engineering
- Strategy Development
- Quality Assurance
- Auditing
- Military Background
- Implementation
- Written Communication
- Education Experience
- Mentoring
- Documentation
- Employee Development
- Interpersonal Skills
- Reporting
- Collaboration
- Coaching
- Policy Development
- Filing
- Bachelor's Degree
- Regulations
- Project Management
- Problem Solving
- Microsoft Excel
- Teamwork
- Research Skills
- Time Management
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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