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.
Regulatory Affairs Manager Regulatory Reporting
- Essity
- Philadelphia, PA (23 miles from West Chester, PA)
- 10 hours ago
- Philadelphia, PA (23 miles from West Chester, PA)
- 10 hours ago
Regulatory Affairs Manager Regulatory Reporting Who We Are Essity is a global leader in health and hygiene headquartered in Stockholm, Sweden, with a North American headquarters located in...
In Person- Merck Sharp Dohme
- North Wales, PA (24 miles from West Chester, PA)
- 11 days ago
- North Wales, PA (24 miles from West Chester, PA)
- 11 days ago
Director level), Regulatory Affairs CMC, provides strategic and technical regulatory expertise in support of dry powder inhaler (DPI) combination products across the product lifecycle, from development...
In PersonDirector Regulatory Affairs Innovative Medicines (IM) Labeling
- Teva Pharmaceutical Industries
- West Chester, PA
- 11 days ago
- West Chester, PA
- 11 days ago
Our Team, Your Impact The Director of Regulatory Affairs, Innovative Medicines (IM) Labeling serves as a cross-functional subject matter expert for matters related to US drug product labeling, including...
In Person- ICON
- Blue Bell, PA (21 miles from West Chester, PA)
- 12 days ago
- Blue Bell, PA (21 miles from West Chester, PA)
- 12 days ago
Director, Regulatory Affairs Due to a number of exciting new projects being awarded to ICON, we are seeking to expand our team and expertise, with the recruitment of a Director of Regulatory Affairs...
In Person- Jacobs
- Philadelphia, PA (23 miles from West Chester, PA)
- 24 days ago
- Philadelphia, PA (23 miles from West Chester, PA)
- 24 days ago
The Director, Regulatory Affairs leads global regulatory strategy, reporting, compliance, labeling, and regulatory intelligence to support product development, approval, and market expansion....
In PersonExecutive Director, Regulatory Affairs Office of Promotion and Advertising Review (OPAR)
- Merck Sharp Dohme
- North Wales, PA (24 miles from West Chester, PA)
- 26 days ago
- North Wales, PA (24 miles from West Chester, PA)
- 26 days ago
This position will be responsible for the leadership, oversight and direction for the regulatory review function of US Office of Promotion and Advertising Review (OPAR). This role has ad/promo...
Hybrid- Globus Medical Inc.
- Audubon, PA (16 miles from West Chester, PA)
- 30+ days ago
- Audubon, PA (16 miles from West Chester, PA)
- 30+ days ago
Works with Product Development, Clinical Affairs, Quality, Management and other areas of the organization to obtain relevant information and subsequent review of submission content as needed....
In PersonDirector, Regulatory Affairs - CMC
- ICON
- Blue Bell, PA (21 miles from West Chester, PA)
- 60+ days ago
- Blue Bell, PA (21 miles from West Chester, PA)
- 60+ days ago
Director, Regulatory Affairs - CMC ICON plc is a world-leading healthcare intelligence and clinical research organization....
RemoteDirector, Regulatory Affairs, Ex-US
- Larimar Therapeutics
- Philadelphia, PA (23 miles from West Chester, PA)
- 60+ days ago
- Philadelphia, PA (23 miles from West Chester, PA)
- 60+ days ago
Position Summary: Larimar is seeking a Director, Regulatory Affairs, to support the global regulatory strategy and drive regulatory activities for products in development specific to European and other...
In PersonDemographic Data for West Chester, PA
Moving to West Chester, PA? Find some basic demographic data about West Chester, PA below.
Director of Regulatory Affairs Online Courses and Training Opportunities
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Salary for Director of Regulatory Affairs Jobs in West Chester, PA
Required or preferred licenses and certifications for Director of Regulatory Affairs positions.
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
- Biology
- Virology
- Immunology
- Oncology
- Medical Writing
- Drug Development
- Neuroscience
- Biostatistics
- Clinical Trials
- Drug Discovery
- Toxicology
- Biotechnology
- Pharmacovigilance
- Medical Affairs
- Gene Therapy
- ICH GCP
- Quality Management Systems
- 21 CFR 820
- ICH Guidelines
- Good Laboratory Practice
- ISO 13485
- Microbiology
- Document Management
- Research and Development
- Medical Device Sales
- FDA Regulations
- Standard Operating Procedures
- Product Development
- Analytical Skills
- Quality Assurance
- Engineering
- Strategy Development
- Auditing
- Process Improvement
- Documentation
- Coaching
- Mentoring
- Interpersonal Skills
- Writing Skills
- Implementation
- Verbal Communication
- Reporting
- Education Experience
- Collaboration
- Bachelor's Degree
- Regulations
- Research Skills
- Microsoft Office
- Project Management
- Problem Solving
- Staff Supervision
- Scheduling
- Teamwork
- Leadership
- Communication Skills
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