Manager of Regulatory Affairs Jobs in Waltham, 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.
- Boston, MA (10 miles from Waltham, MA)
- moments ago
- Boston, MA (10 miles from Waltham, MA)
- moments ago
Interpret and apply FDA regulations and guidance documents to business practices, evaluating risk and proposing solutions to business challenges based on regulatory strategy....
Sr Director, Regulatory Affairs
- Boston, MA (10 miles from Waltham, MA)
- 23 hours ago
- Boston, MA (10 miles from Waltham, MA)
- 23 hours ago
JOB TITLE: Senior Sales Operations AnalystLOCATION: Seaport, Boston, MA (hybrid 3 days in office)DEPARTMENT: Business AnalyticsDATE PREPARED: 04/22/2025 JOB SUMMARY:The Senior Sales Operations...
Associate Director, Regulatory Affairs (In Vitro Diagnostics & Companion Diagnostics)
- Cambridge, MA (6 miles from Waltham, MA)
- 23 hours ago
- Cambridge, MA (6 miles from Waltham, MA)
- 23 hours ago
Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely...
Senior Manager, Regulatory Affairs Advertising and Promotion
- Boston, MA (10 miles from Waltham, MA)
- 1 day ago
- Boston, MA (10 miles from Waltham, MA)
- 1 day ago
Monitors and keeps organization abreast on US regulatory promotional environment (e.g., the issuance of new FDA regulations/guidance documents, relevant FDA enforcement action and general awareness...
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Associate Director, Regulatory Affairs CMC
- Cambridge, MA (6 miles from Waltham, MA)
- 2 days ago
- Cambridge, MA (6 miles from Waltham, MA)
- 2 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...
Associate Regulatory Affairs Director
- Boston, MA (10 miles from Waltham, MA)
- 2 days ago
- Boston, MA (10 miles from Waltham, MA)
- 2 days ago
Associate Regulatory Affairs Director Introduction to role The Associate Regulatory Affairs Director (ARAD) is an experienced regulatory specialist with strong project management capabilities...
Director, Regulatory Affairs, Advertising and Promotion
- Bedford, MA (7 miles from Waltham, MA)
- 3 days ago
- Bedford, MA (7 miles from Waltham, MA)
- 3 days ago
Act as a subject matter expert on FDA regulations, guidance, enforcement trends and policy issues relevant to promotion and labeling....
Director, Regulatory Affairs, Specialty
- Cambridge, MA (6 miles from Waltham, MA)
- 3 days ago
- Cambridge, MA (6 miles from Waltham, MA)
- 3 days ago
Site Name: USA - Pennsylvania - Upper Providence, Cambridge Park Drive, Collegeville TSA, USA - Maryland - Rockville Posted Date: Apr 29 2025 Job Purpose Ensure the development of appropriate...
Senior Manager, Regulatory Affairs
- Salem, MA (19 miles from Waltham, MA)
- 4 days ago
- Salem, MA (19 miles from Waltham, MA)
- 4 days ago
Job Overview We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Senior Manager, Regulatory Affairs....
Sr Director, Regulatory Affairs Advertising, Promotion & Labeling
- Cambridge, MA (6 miles from Waltham, MA)
- 6 days ago
- Cambridge, MA (6 miles from Waltham, MA)
- 6 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 Work- Cambridge, MA (6 miles from Waltham, MA)
- 7 days ago
- Cambridge, MA (6 miles from Waltham, MA)
- 7 days ago
Director, Regulatory Affairs Cambridge, MA | On-site An innovative biotech company based in Cambridge is seeking a Director of Regulatory Affairs to serve as the organization's first regulatory...
Director, Regulatory Affairs Strategy
- Boston, MA (10 miles from Waltham, MA)
- 9 days ago
- Boston, MA (10 miles from Waltham, MA)
- 9 days ago
Location: REMOTE Salary: $190,000.00 USD Annually - $215,000.00 USD Annually Description: Our client is currently seeking a Director, Regulatory Affairs Strategy who will be responsible for...
Quality Systems & Regulatory Affairs Manager
- Boston, MA (10 miles from Waltham, MA)
- 10 days ago
- Boston, MA (10 miles from Waltham, MA)
- 10 days ago
management and regulatory strategy within WHOOP Support development and maintenance of WHOOPs FDA-compliant QMS, ensuring adherence to 21 CFR 820 and ISO 13485:2016 Coordinate and lead internal audits...
- Wellesley Hills, MA (6 miles from Waltham, MA)
- 10 days ago
- Wellesley Hills, MA (6 miles from Waltham, MA)
- 10 days ago
Manager, Regulatory Affairs based at our corporate headquarters in Wellesley, MA....
Associate Director, Regulatory Affairs CMC
- Cambridge, MA (6 miles from Waltham, MA)
- 16 days ago
- Cambridge, MA (6 miles from Waltham, MA)
- 16 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...
Demographic Data for Waltham, MA
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Salary for Manager of Regulatory Affairs Jobs in Waltham, MA
Required or preferred licenses and certifications for Manager of Regulatory Affairs positions.
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Manager of Regulatory Affairss in Waltham, 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
- Medical Terminology
- Clinical Research
- Biology
- Immunology
- Oncology
- Assay Development
- Neurology
- Drug Development
- Clinical Trials
- Drug Discovery
- Biotechnology
- Next-Generation Sequencing
- Pharmacovigilance
- Medical Affairs
- Gene Therapy
- Biomarkers
- Internal Audits
- Quality Systems
- Quality Management Systems
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Change Control
- Medical Device Sales
- FDA Regulations
- Document Management
- Research and Development
- Resolution
- Product Development
- Engineering
- Strategy Development
- Quality Assurance
- Military Background
- Implementation
- Auditing
- Investigation
- Written Communication
- Verbal Communication
- Documentation
- Mentoring
- Collaboration
- Interpersonal Skills
- Reporting
- Education Experience
- Bachelor's Degree
- Coaching
- Regulations
- Project Management
- Problem Solving
- Microsoft Excel
- Research Skills
- Staff Supervision
- Organization
- Leadership
- Communication Skills
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