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.
- Acton, MA (19 miles from Westborough, MA)
- 4 days ago
- Acton, MA (19 miles from Westborough, MA)
- 4 days ago
Job Title: Director, Regulatory Affairs Department: Regulatory Affairs and Compliance Manager/Supervisor: Sr....
Senior Manager, Regulatory Affairs CMC (Hybrid Onsite)
- Waltham, MA (20 miles from Westborough, MA)
- 8 days ago
- Waltham, MA (20 miles from Westborough, MA)
- 8 days ago
Company Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive...
Director of Regulatory Affairs
- Watertown, MA (22 miles from Westborough, MA)
- 30+ days ago
- Watertown, MA (22 miles from Westborough, MA)
- 30+ days ago
The Role Reporting to the Chief Medical Officer, the Director of Regulatory Affairs will be responsible for developing and implementing global strategies to secure and maintain market approval for product...
Program Manager, Regulatory Affairs - Remote Job Details Olympus Corporation of the Americas
- Westborough, MA
- 30+ days ago
- Westborough, MA
- 30+ days ago
Working Location: NATIONWIDE Workplace Flexibility: Field For more than 100 years, Olympus has focused on making people's lives healthier, safer and more fulfilling. Every day, we live by our...
Senior 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 Senior Director, Regulatory Affairs helps drive forward our regulatory strategy and operational activities related to Dyne's muscle disease programs....
Demographic Data for Westborough, MA
Moving to Westborough, MA? Find some basic demographic data about Westborough, MA below.
Director of Regulatory Affairs Online Courses and Training Opportunities
Title Synonyms
Users interested in this job title also searched for the following job title
Salary for Director of Regulatory Affairs Jobs in Westborough, MA
Required or preferred licenses and certifications for Director of Regulatory Affairs positions.
Highest Education Level
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
- Drug Development
- Clinical Trials
- Drug Discovery
- Biotechnology
- Pharmacovigilance
- Medical Affairs
- Masters In Education
- Gene Therapy
- Quality Systems
- Supplier Auditing
- Quality Management Systems
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Change Control
- GxP
- Good Manufacturing Practices
- Product Launch
- Document Management
- Medical Device Sales
- Research and Development
- FDA Regulations
- Standard Operating Procedures
- Product Development
- Engineering
- Strategy Development
- Quality Assurance
- Process Improvement
- Auditing
- Military Background
- Implementation
- Written Communication
- Education Experience
- Mentoring
- Documentation
- Employee Development
- Reporting
- Coaching
- Collaboration
- Interpersonal Skills
- Filing
- Bachelor's Degree
- Policy Development
- Regulations
- Project Management
- Problem Solving
- Research Skills
- Time Management
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
Other Career Titles
Here are some other career titles that require similar skills
Director of Regulatory Affairs Related Career Advice Articles
Top Skills and Quality Control Training You Need to Get Promoted
Ready to take your quality control career to the next level? Seek out quality control training for these highly desired skills for quality control jobs.
Read article »
Quality Assurance vs. Quality Control: What’s the Difference?
Deciding on a career in QA vs. QC can be tough if you don’t know which is which. Find out the difference between quality control and quality assurance.
Read article »