Director of Regulatory Affairs Jobs in Upper Gwynedd, PA
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.
Principal Scientist (Director) - Regulatory Affairs-CMC
- North Wales, PA (3 miles from Upper Gwynedd, PA)
- 5 days ago
- North Wales, PA (3 miles from Upper Gwynedd, PA)
- 5 days ago
Director, Combination Product Regulatory CMC - (R5) This Principal Scientist position is equivalent to a Director position. Under direction from the Combination Product Regulatory CMC Team Leader,...
Principal Scientist (Director) - Regulatory Affairs-CMC
- Upper Gwynedd, PA
- 7 days ago
- Upper Gwynedd, PA
- 7 days ago
Job Description Director, Combination Product Regulatory CMC - (R5) This Principal Scientist position is equivalent to a Director position. Under direction from the Combination Product Regulatory...
Director, Regulatory Affairs - Dossier Project Manager
- West Chester, PA (23 miles from Upper Gwynedd, PA)
- 13 days ago
- West Chester, PA (23 miles from Upper Gwynedd, PA)
- 13 days ago
Who we are Together, we're on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It's a mission that bonds our people across...
- Philadelphia, PA (20 miles from Upper Gwynedd, PA)
- 21 days ago
- Philadelphia, PA (20 miles from Upper Gwynedd, PA)
- 21 days ago
Regulatory Affairs Manager Who We Are Essity is a global leader in health and hygiene headquartered in Stockholm, Sweden, with a North American headquarters located in Philadelphia, PA. We are a...
Director, Regulatory Affairs - Specialty (Infectious Disease, HIV)
- Collegeville, PA (7 miles from Upper Gwynedd, PA)
- 30+ days ago
- Collegeville, PA (7 miles from Upper Gwynedd, PA)
- 30+ days ago
Site Name: Durham Blackwell Street, USA - Pennsylvania - Upper Providence Posted Date: Jun 10 2025 Job Purpose Ensure the development of appropriate regional regulatory strategy(s) and their...
Director, Regulatory Affairs Strategy
- Philadelphia, PA (20 miles from Upper Gwynedd, PA)
- 30+ days ago
- Philadelphia, PA (20 miles from Upper Gwynedd, PA)
- 30+ 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 contributing...
- West Chester, PA (23 miles from Upper Gwynedd, PA)
- 45+ days ago
- West Chester, PA (23 miles from Upper Gwynedd, PA)
- 45+ days ago
Who we are Together, we're on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It's a mission that bonds our people across...
Demographic Data for Upper Gwynedd, PA
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Salary for Director of Regulatory Affairs Jobs in Upper Gwynedd, PA
Required or preferred licenses and certifications for Director of Regulatory Affairs positions.
Highest Education Level
Director of Regulatory Affairss in Upper Gwynedd, PA offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Director of Regulatory Affairs position
- Molecular Biology
- Biochemistry
- Data Management
- Process Development
- Biology
- Immunology
- Hazardous Materials
- Scientific Writing
- Drug Development
- Gene Therapy
- Quality Systems
- Quality Management Systems
- Supplier Auditing
- 21 CFR 820
- ICH Guidelines
- Corrective Actions & Preventive Actions
- ISO 13485
- Quality Management
- GxP
- Electrical Engineering
- Control Systems
- Microbiology
- Document Control
- Inspections
- Medical Device Sales
- FDA Regulations
- Research and Development
- Diagnostic
- Product Development
- Affirmative Action
- Engineering
- Strategy Development
- Quality Assurance
- Auditing
- Implementation
- Written Communication
- Mentoring
- Employee Development
- Collaboration
- Documentation
- Reporting
- Coaching
- Regulations
- Bachelor's Degree
- Policy Development
- English
- Project Management
- Problem Solving
- Team Building
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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