Director of Regulatory Affairs Jobs in Boston, MA
The Director of Regulatory Affairs in the quality control industry plays an essential role in ensuring that the company's products meet all regulatory standards and compliance requirements. This individual oversees the development and implementation of regulatory strategies for new and existing products, supervises the preparation of regulatory submissions, and maintains communication with regulatory authorities. They also monitor changes in regulations, interpret these updates for relevant departments within the company, and implement necessary changes to maintain compliance. They are responsible for setting the company's standards for quality, safety, and efficacy.
To excel in this role, one should possess excellent analytical skills, strategic thinking, and strong leadership abilities. A deep understanding of regulatory guidelines, ability to interpret complex regulations, and excellent communication skills are essential. They should have a degree in a relevant field, along with certifications such as Regulatory Affairs Certification (RAC), Certified Quality Auditor (CQA), and Certified Quality Engineer (CQE). Prior to becoming a Director of Regulatory Affairs, individuals might have roles such as Regulatory Affairs Specialist, Regulatory Affairs Manager, or Quality Control Manager.
Senior Manager, Regulatory Affairs - CMC
- Waltham, MA (10 miles from Boston, MA)
- 4 days ago
- Waltham, MA (10 miles from Boston, MA)
- 4 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...
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 (3 miles from Boston, MA)
- 7 days ago
- Cambridge, MA (3 miles from Boston, MA)
- 7 days 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
- 7 days ago
- Boston, MA
- 7 days 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 (3 miles from Boston, MA)
- 8 days ago
- Cambridge, MA (3 miles from Boston, MA)
- 8 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 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 (14 miles from Boston, MA)
- 9 days ago
- Bedford, MA (14 miles from Boston, MA)
- 9 days ago
Summary of role The Director of Regulatory Affairs, Advertising and Promotions will be responsible for leading the Regulatory Advertising and Promotion activities for the assigned therapeutic area....
Director, Regulatory Affairs, Specialty
- Cambridge, MA (3 miles from Boston, MA)
- 10 days ago
- Cambridge, MA (3 miles from Boston, MA)
- 10 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 (13 miles from Boston, MA)
- 11 days ago
- Salem, MA (13 miles from Boston, MA)
- 11 days ago
Job Listing ID: 4259842 Job Title: Senior Manager, Regulatory Affairs Application Deadline: Open Until FilledJob Location: Salem Date Posted: 04/25/2025Hours Worked Per Week: Not Provided Shift:...
Sr Director, Regulatory Affairs Advertising, Promotion & Labeling
- Cambridge, MA (3 miles from Boston, MA)
- 12 days ago
- Cambridge, MA (3 miles from Boston, MA)
- 12 days ago
The Senior Director Regulatory Affairs Advertising, Promotion & Labeling (Sr. Dir....
Remote Work- Cambridge, MA (3 miles from Boston, MA)
- 14 days ago
- Cambridge, MA (3 miles from Boston, MA)
- 14 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 hire...
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 contributing...
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...
Sr. Manager, Regulatory Affairs
- Wellesley Hills, MA (11 miles from Boston, MA)
- 17 days ago
- Wellesley Hills, MA (11 miles from Boston, MA)
- 17 days ago
Sr. Manager, Regulatory Affairs About Climb Bio: Climb Bio is a clinical-stage biotechnology company developing therapeutics for patients with immune-mediated diseases. Our product candidates...
Associate Director, Regulatory Affairs CMC
- Cambridge, MA (3 miles from Boston, MA)
- 22 days ago
- Cambridge, MA (3 miles from Boston, MA)
- 22 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 Boston, MA
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Salary for Director of Regulatory Affairs Jobs in Boston, MA
Required or preferred licenses and certifications for Director of Regulatory Affairs positions.
Highest Education Level
Director of Regulatory Affairss in Boston, MA offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Director 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
- Gene Therapy
- Biomarkers
- Internal Audits
- Quality Management Systems
- Quality Systems
- ICH Guidelines
- ISO 13485
- Change Control
- Medical Device Sales
- FDA Regulations
- Document Management
- Research and Development
- Resolution
- Standard Operating Procedures
- 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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