Director of Regulatory Affairs Jobs in Westborough, 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.
Director, Regulatory Affairs- Usona Institute
- Fitchburg, MA (24 miles from Westborough, MA)
- 11 hours ago
- Fitchburg, MA (24 miles from Westborough, MA)
- 11 hours ago
Comprehensive knowledge of relevant FDA regulations, ICH guidelines, and global regulatory frameworks....
Working Location: MASSACHUSETTS, WESTBOROUGH; NATIONWIDE Workplace Flexibility: Field For more than 100 years, Olympus has focused on making peoples lives healthier, safer and more fulfilling....
Executive Director, Regulatory Affairs & Quality Assurance.
- Waltham, MA (20 miles from Westborough, MA)
- 10 days ago
- Waltham, MA (20 miles from Westborough, MA)
- 10 days ago
Executive Director, Regulatory Affairs & Quality Assurance....
Manager, Regulatory Affairs (IVD On-Market/Sustaining)
- Marlborough, MA (6 miles from Westborough, MA)
- 11 days ago
- Marlborough, MA (6 miles from Westborough, 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...
Senior Manager, Regulatory Affairs - CMC
- Waltham, MA (20 miles from Westborough, MA)
- 30+ days ago
- Waltham, MA (20 miles from Westborough, 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...
Sr. Manager, Regulatory Affairs
- Wellesley Hills, MA (17 miles from Westborough, MA)
- 45+ days ago
- Wellesley Hills, MA (17 miles from Westborough, 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...
Senior Director, Regulatory Affairs
- Waltham, MA (20 miles from Westborough, MA)
- 60+ days ago
- Waltham, MA (20 miles from Westborough, MA)
- 60+ days ago
Role Summary: The Senior Director, Regulatory Affairs helps drive forward our regulatory strategy and operational activities related to Dyne's muscle disease programs....
Associate Director, Regulatory Affairs
- Waltham, MA (20 miles from Westborough, MA)
- 90+ days ago
- Waltham, MA (20 miles from Westborough, MA)
- 90+ days ago
Role Summary: The Associate Director, Regulatory Affairs will help drive forward our regulatory strategy and operational activities related to Dyne's muscle disease programs....
Demographic Data for Westborough, MA
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Salary for Director of Regulatory Affairs Jobs in Westborough, MA
Required or preferred licenses and certifications for Director of Regulatory Affairs positions.
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Director of Regulatory Affairss in Westborough, 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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