Director of Regulatory Affairs Jobs in Collegeville, 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.
- Philadelphia, PA (21 miles from Collegeville, PA)
- 2 days ago
- Philadelphia, PA (21 miles from Collegeville, PA)
- 2 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
- 15 days ago
- Collegeville, PA
- 15 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 (21 miles from Collegeville, PA)
- 21 days ago
- Philadelphia, PA (21 miles from Collegeville, PA)
- 21 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 (16 miles from Collegeville, PA)
- 25 days ago
- West Chester, PA (16 miles from Collegeville, PA)
- 25 days ago
Teva Pharmaceuticals USA Inc. seeks a Regulatory Affairs Manager in our West Chester, PA office to: evaluate Change Requests/Change Controls and provide accurate regulatory assessments for changes...
- West Chester, PA (16 miles from Collegeville, PA)
- 30+ days ago
- West Chester, PA (16 miles from Collegeville, 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...
Associate Director, Regulatory Affairs
- Malvern, PA (11 miles from Collegeville, PA)
- 45+ days ago
- Malvern, PA (11 miles from Collegeville, PA)
- 45+ days ago
Associate Director, Regulatory Affairs City : Malvern State : PA Country : US Job Term : Permanent Overview : PharmaLogics Recruiting is seeking an Associate Director, Regulatory Affairs in Malvern,...
Demographic Data for Collegeville, PA
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Director of Regulatory Affairss in Collegeville, 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
- 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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