Director of Regulatory Affairs Jobs in Woburn, 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
- Cambridge, MA (7 miles from Woburn, MA)
- 3 hours ago
- Cambridge, MA (7 miles from Woburn, 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...
Associate Director, Regulatory Affairs Strategy
- Cambridge, MA (7 miles from Woburn, MA)
- 7 hours ago
- Cambridge, MA (7 miles from Woburn, MA)
- 7 hours ago
Associate Director, Regulatory Affairs Strategy Who we are: Agios is a biopharmaceutical company that is fueled by connections....
Assoc Dir/Director, Regulatory Affairs
- Boston, MA (10 miles from Woburn, MA)
- 3 days ago
- Boston, MA (10 miles from Woburn, MA)
- 3 days ago
ESSENTIAL JOB FUNCTIONS: The Assoc Dir/Director, Regulatory Affairs will be responsible for developing, implementing, and providing guidance on US and global regulatory strategies to support development...
Executive Director, Regulatory Affairs & Quality Assurance.
- Waltham, MA (8 miles from Woburn, MA)
- 10 days ago
- Waltham, MA (8 miles from Woburn, MA)
- 10 days ago
Executive Director, Regulatory Affairs & Quality Assurance....
Manager, Regulatory Affairs (IVD On-Market/Sustaining)
- Marlborough, MA (22 miles from Woburn, MA)
- 11 days ago
- Marlborough, MA (22 miles from Woburn, 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...
Director, Regulatory Affairs, Regulatory Science & Execution
- Boston, MA (10 miles from Woburn, MA)
- 15 days ago
- Boston, MA (10 miles from Woburn, 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...
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, Regulatory Affairs - CMC
- Cambridge, MA (7 miles from Woburn, MA)
- 30+ days ago
- Cambridge, MA (7 miles from Woburn, MA)
- 30+ days ago
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 million....
- Cambridge, MA (7 miles from Woburn, MA)
- 30+ days ago
- Cambridge, MA (7 miles from Woburn, MA)
- 30+ days ago
Job Summary: Akebia is currently expanding its Regulatory team to support early and late-stage assets and is searching for a Senior Director, Regulatory Affairs to support the continued development...
Senior Manager, Regulatory Affairs - CMC
- Waltham, MA (8 miles from Woburn, MA)
- 30+ days ago
- Waltham, MA (8 miles from Woburn, 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 (7 miles from Woburn, MA)
- 30+ days ago
- Cambridge, MA (7 miles from Woburn, 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 (10 miles from Woburn, MA)
- 45+ days ago
- Boston, MA (10 miles from Woburn, 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...
Sr. Manager, Regulatory Affairs
- Wellesley Hills, MA (13 miles from Woburn, MA)
- 45+ days ago
- Wellesley Hills, MA (13 miles from Woburn, MA)
- 45+ 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...
Regulatory Affairs Director, Global Regulatory Strategy
- Boston, MA (10 miles from Woburn, MA)
- 60+ days ago
- Boston, MA (10 miles from Woburn, MA)
- 60+ days ago
Position Summary: The Regulatory Affairs Director (RAD), Global Regulatory Strategy will be responsible for the development and implement ation of global regulatory strategies for all assigned...
- Burlington, MA (2 miles from Woburn, MA)
- 60+ days ago
- Burlington, MA (2 miles from Woburn, MA)
- 60+ days ago
Position Summary: The Director, Regulatory Affairs manages, evaluates and completes regulatory projects consistent with the company goals....
Demographic Data for Woburn, MA
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Director of Regulatory Affairss in Woburn, 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
- 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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