Director of Regulatory Affairs Jobs in West Chester, 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.
Manager, Regulatory Affairs, CMC Vaccines
- Collegeville, PA (16 miles from West Chester, PA)
- 11 hours ago
- Collegeville, PA (16 miles from West Chester, PA)
- 11 hours ago
Site Name: Belgium-Wavre, GSK HQ, India - Karnataka - Vemgal Bangalore Site, Italy - Siena, Poznan Business Garden, Rixensart, UK - Hertfordshire - Stevenage, USA - Maryland - Rockville, USA -...
Senior Manager, Regulatory Affairs
- Philadelphia, PA (23 miles from West Chester, PA)
- 1 day ago
- Philadelphia, PA (23 miles from West Chester, PA)
- 1 day ago
Senior Manager, Regulatory Affairs JOB DETAILS REQ ID:R010528 LOCATION:Philadelphia, PA -- [Remote/Home-Based] CATEGORY:Research & Development If you are a current Jazz employee please apply via...
Senior Director, Regulatory Affairs
- Philadelphia, PA (23 miles from West Chester, PA)
- 1 day ago
- Philadelphia, PA (23 miles from West Chester, PA)
- 1 day ago
The Senior Director of Regulatory Affairs will define and implement innovative regulatory strategies that expedite the development and approval of our portfolio of investigational products....
Associate Director, Regulatory Affairs - Labeling Management
- North Wales, PA (24 miles from West Chester, PA)
- 7 days ago
- North Wales, PA (24 miles from West Chester, PA)
- 7 days ago
Regulations, Management Process, Pharmacovigilance, Policy Implementation, Regulatory Affairs Compliance, Regulatory Compliance, Regulatory Labeling, Regulatory Operations, Regulatory Submissions,...
Associate Director, Regulatory Affairs CMC
- Radnor, PA (11 miles from West Chester, PA)
- 9 days ago
- Radnor, PA (11 miles from West Chester, PA)
- 9 days ago
Reporting to the Executive Director, Regulatory Affairs - CMC, the Associate Director of Regulatory Affairs-CMC is responsible for leading regulatory support for assigned programs to ensure sound regulatory...
- Collegeville, PA (16 miles from West Chester, PA)
- 12 days ago
- Collegeville, PA (16 miles from West Chester, PA)
- 12 days ago
We're looking for a Director, Regulatory Affairs to lead the development and execution of regulatory strategies for our cutting-edge Specialty pipeline....
Regulatory Affairs Manager, Designed Enzymatic Biomaterials
- Wilmington, DE (19 miles from West Chester, PA)
- 14 days ago
- Wilmington, DE (19 miles from West Chester, PA)
- 14 days ago
IFF applies expert science to advance market-driven, healthy, and sustainable solutions for the food, beverage, dietary supplement, pharmaceutical and materials industries. In the Global...
Associate Manager, Regulatory Affairs
- Wilmington, DE (19 miles from West Chester, PA)
- 14 days ago
- Wilmington, DE (19 miles from West Chester, PA)
- 14 days ago
The Associate Manager, Regulatory Affairs will combine expertise in knowledge management and regulatory documentation with strong project management skills to build a robust infrastructure that...
Director, Regulatory Affairs - Specialty Medicine
- Collegeville, PA (16 miles from West Chester, PA)
- 17 days ago
- Collegeville, PA (16 miles from West Chester, PA)
- 17 days ago
Were looking for a Director, Regulatory Affairs to lead the development and execution of regulatory strategies for our cutting-edge Specialty pipeline....
Regulatory Affairs Director (US)
- Wilmington, DE (19 miles from West Chester, PA)
- 20 days ago
- Wilmington, DE (19 miles from West Chester, PA)
- 20 days ago
As we create a colorful, capable and cleaner world through chemistry, we invite you to join our team to harness the power of chemistry to shape markets, redefine industries and improve lives for...
Director, Regulatory Affairs - Dossier Project Manager
- West Chester, PA
- 30+ days ago
- West Chester, PA
- 30+ 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 (23 miles from West Chester, PA)
- 45+ days ago
- Philadelphia, PA (23 miles from West Chester, PA)
- 45+ 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...
Demographic Data for West Chester, PA
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Salary for Director of Regulatory Affairs Jobs in West Chester, PA
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Highest Education Level
Director of Regulatory Affairss in West Chester, 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
- Clinical Research
- Biochemistry
- Biology
- Immunology
- Scientific Writing
- Drug Development
- Clinical Trials
- Biotechnology
- Pharmacovigilance
- Medical Affairs
- Masters In Education
- Gene Therapy
- Internal Audits
- Quality Systems
- Supplier Auditing
- Quality Management Systems
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Change Control
- GxP
- Microbiology
- Product Launch
- Document Management
- Medical Device Sales
- Research and Development
- FDA Regulations
- Standard Operating Procedures
- Product Development
- Engineering
- Strategy Development
- Quality Assurance
- Auditing
- Military Background
- Implementation
- Written Communication
- Education Experience
- Mentoring
- Verbal Communication
- 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
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