Manager of Regulatory Affairs Jobs in Wellesley Hills, 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 (8 miles from Wellesley Hills, MA)
- 3 hours ago
- Cambridge, MA (8 miles from Wellesley Hills, MA)
- 3 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 (8 miles from Wellesley Hills, MA)
- 7 hours ago
- Cambridge, MA (8 miles from Wellesley Hills, MA)
- 7 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 (11 miles from Wellesley Hills, MA)
- 3 days ago
- Boston, MA (11 miles from Wellesley Hills, 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...
Program Manager, Regulatory Affairs - Remote
- Westborough, MA (17 miles from Wellesley Hills, MA)
- 3 days ago
- Westborough, MA (17 miles from Wellesley Hills, MA)
- 3 days ago
Job Description Assist the Manager, Regulatory Affairs in obtaining approval to market Olympus medical devices in the markets served by Olympus Job Duties Facilitate development of regulatory strategy...
Executive Director, Regulatory Affairs & Quality Assurance.
- Waltham, MA (6 miles from Wellesley Hills, MA)
- 10 days ago
- Waltham, MA (6 miles from Wellesley Hills, 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 (14 miles from Wellesley Hills, MA)
- 11 days ago
- Marlborough, MA (14 miles from Wellesley Hills, 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 (11 miles from Wellesley Hills, MA)
- 15 days ago
- Boston, MA (11 miles from Wellesley Hills, 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 (13 miles from Wellesley Hills, MA)
- 23 days ago
- Woburn, MA (13 miles from Wellesley Hills, 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...
Director of Regulatory Affairs
- Stoughton, MA (15 miles from Wellesley Hills, MA)
- 30+ days ago
- Stoughton, MA (15 miles from Wellesley Hills, MA)
- 30+ days ago
Develop regulatory strategies integrated with cross functional project teams and external stakeholders to facilitate timely subscriptions and approvals for post market regulatory submissions....
Sr. Director, Regulatory Affairs - CMC
- Cambridge, MA (8 miles from Wellesley Hills, MA)
- 30+ days ago
- Cambridge, MA (8 miles from Wellesley Hills, 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 (8 miles from Wellesley Hills, MA)
- 30+ days ago
- Cambridge, MA (8 miles from Wellesley Hills, 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 (6 miles from Wellesley Hills, MA)
- 30+ days ago
- Waltham, MA (6 miles from Wellesley Hills, 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 (8 miles from Wellesley Hills, MA)
- 30+ days ago
- Cambridge, MA (8 miles from Wellesley Hills, 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 (11 miles from Wellesley Hills, MA)
- 45+ days ago
- Boston, MA (11 miles from Wellesley Hills, 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...
Manager, Regulatory Affairs based at our corporate headquarters in Wellesley, MA....
Demographic Data for Wellesley Hills, MA
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Salary for Manager of Regulatory Affairs Jobs in Wellesley Hills, MA
Required or preferred licenses and certifications for Manager of Regulatory Affairs positions.
Highest Education Level
Manager of Regulatory Affairss in Wellesley Hills, 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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