Manager of Regulatory Affairs Jobs in Pennsylvania
A Manager of Regulatory Affairs in the quality control industry plays a pivotal role in ensuring that the company's products meet all necessary regulatory standards. Their key responsibilities include developing and implementing regulatory strategies, monitoring changes to regulatory guidelines, and ensuring the organization's compliance with these changes. They also engage in the preparation, review, and submission of regulatory documents to regulatory agencies. To effectively execute these responsibilities, they liaise with various stakeholders within and outside the organization, such as product developers, project managers, and regulatory bodies.
Important skills and certifications for a Manager of Regulatory Affairs include strong organizational and project management skills, excellent written and verbal communication skills, as well as a keen eye for detail. Analytical thinking and problem-solving skills are also crucial in this role. Additionally, they should possess relevant certifications such as the Regulatory Affairs Certification (RAC), which is recognized worldwide as the leading credential for regulatory professionals in the healthcare product sector. Before becoming a Manager of Regulatory Affairs, a person may have roles such as a Regulatory Affairs Specialist, Quality Control Analyst, or a Quality Assurance Associate. These roles would provide the necessary exposure and experience in quality control and regulatory affairs needed for the managerial position.
If you have what it takes to become part of the Vistra family and would like to start a promising career with a global leader, take a look at the exciting employment opportunities that are...
Remote Director of Regulatory Affairs McKesson Corporation United States, Pennsylvania Jul 03, 2025 McKesson is an impact-driven, Fortune 10 company that touches virtually every aspect of...
Remote WorkWhat You Will Do The Manager, Regulatory Affairs, will report to the VP of Government and Regulatory Affairs....
Principal Scientist (Director) - Regulatory Affairs-CMC
- North Wales, PA
- 15 days ago
- North Wales, PA
- 15 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,...
Director, Regulatory Affairs - Dossier Project Manager
- West Chester, PA
- 23 days ago
- West Chester, PA
- 23 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...
Make a meaningful difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex domestic and international...
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
- 30+ days ago
- Collegeville, 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...
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...
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 Pennsylvania
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Salary for Manager of Regulatory Affairs Jobs in Pennsylvania
Required or preferred licenses and certifications for Manager of Regulatory Affairs positions.
Highest Education Level
Manager of Regulatory Affairss in Pennsylvania offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Manager of Regulatory Affairs position
- Clinical Research
- Biochemistry
- Biology
- Immunology
- Medical Writing
- Scientific Writing
- Drug Development
- Clinical Trials
- Biotechnology
- Pharmacovigilance
- Medical Affairs
- Masters In Education
- Gene Therapy
- ICH GCP
- Quality Systems
- Quality Management Systems
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- GxP
- Microbiology
- Medical Device Sales
- Document Management
- Product Launch
- FDA Regulations
- Research and Development
- Standard Operating Procedures
- Product Development
- Engineering
- Strategy Development
- Quality Assurance
- Auditing
- Implementation
- Military Background
- Written Communication
- Mentoring
- Interpersonal Skills
- Employee Development
- Collaboration
- Documentation
- Reporting
- Coaching
- Filing
- Regulations
- Policy Development
- Bachelor's Degree
- Microsoft PowerPoint
- Microsoft Office
- Project Management
- Problem Solving
- Microsoft Excel
- Sales
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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