Director of Regulatory Affairs Jobs in Malvern, 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.
CMC Regulatory Affairs Manager
- Collegeville, PA (11 miles from Malvern, PA)
- 1 day ago
- Collegeville, PA (11 miles from Malvern, PA)
- 1 day ago
Site Name: Durham Blackwell Street, Upper Providence Posted Date: May 9 2025 If you are dedicated to ensuring supply continuity of medicines to patients, then this role presents an exciting...
- West Chester, PA (5 miles from Malvern, PA)
- 6 days ago
- West Chester, PA (5 miles from Malvern, PA)
- 6 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...
Director, Regulatory Affairs, Specialty
- Collegeville, PA (11 miles from Malvern, PA)
- 12 days ago
- Collegeville, PA (11 miles from Malvern, PA)
- 12 days ago
Site Name: USA - Pennsylvania - Upper Providence, Cambridge Park Drive, Collegeville TSA, USA - Maryland - Rockville Posted Date: Apr 29 2025 Job Purpose Ensure the development of appropriate...
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,...
- Philadelphia, PA (20 miles from Malvern, PA)
- 30+ days ago
- Philadelphia, PA (20 miles from Malvern, PA)
- 30+ days ago
The Manager of Regulatory Affairs executes the readiness processes to ensure compliance with regulations and standards of regulatory and accreditation agencies. Assesses and determines survey...
Director, Regulatory Affairs - Specialty (Infectious Disease, HIV)
- Collegeville, PA (11 miles from Malvern, PA)
- 45+ days ago
- Collegeville, PA (11 miles from Malvern, PA)
- 45+ days ago
Site Name: Durham Blackwell Street, USA - Pennsylvania - Upper Providence Posted Date: Mar 20 2025 Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global...
Demographic Data for Malvern, PA
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Salary for Director of Regulatory Affairs Jobs in Malvern, PA
Required or preferred licenses and certifications for Director of Regulatory Affairs positions.
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Director of Regulatory Affairss in Malvern, 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
- Polymerase Chain Reaction
- Biology
- Immunology
- Assay Development
- Drug Development
- Clinical Trials
- Drug Discovery
- Biotechnology
- Next-Generation Sequencing
- Pharmacovigilance
- Medical Affairs
- Gene Therapy
- Biomarkers
- Institutional Review Board
- Internal Audits
- Quality Management Systems
- Quality Systems
- ICH Guidelines
- GxP
- ISO 13485
- Change Control
- Microbiology
- Medical Device Sales
- Product Launch
- FDA Regulations
- Document Management
- Research and Development
- Resolution
- Standard Operating Procedures
- Diagnostic
- Product Development
- Engineering
- Strategy Development
- Quality Assurance
- Process Improvement
- Military Background
- Implementation
- Auditing
- Written Communication
- Verbal Communication
- Documentation
- Mentoring
- Collaboration
- Interpersonal Skills
- Reporting
- Education Experience
- Bachelor's Degree
- Coaching
- Regulations
- Critical Thinking
- Policy Development
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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