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.
Associate Director, Regulatory Affairs - Labeling Management
- North Wales, PA
- 5 days ago
- North Wales, PA
- 5 days ago
Regulations, Management Process, Pharmacovigilance, Policy Implementation, Regulatory Affairs Compliance, Regulatory Compliance, Regulatory Labeling, Regulatory Operations, Regulatory Submissions,...
Cytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle...
Collegeville, PA 3 DAYS AGO 21622174 Summary Collegeville, PA Competitive Salary 1 Years Experience Bachelor's degree No Commisssion 40.00 hours per week / Day Shift /Full-Time Description...
Director, Regulatory Affairs - Specialty Medicine Join GSK as a Regulatory Director - Drive Innovation in Specialty Medicines Are you ready to make a meaningful impact in the world of specialty...
Director, Regulatory Affairs - Specialty Medicine
- Collegeville, PA
- 15 days ago
- Collegeville, PA
- 15 days ago
Site Name: USA - Pennsylvania - Upper Providence, Cambridge MA, USA - North Carolina - Durham Posted Date: Jul 15 2025 Director, Regulatory Affairs Specialty Medicine Join GSK as a Regulatory...
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...
What You Will Do The Manager, Regulatory Affairs, will report to the VP of Government and Regulatory Affairs....
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...
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...
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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
- Drug Discovery
- 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
- Medical Device Sales
- Product Launch
- Document Management
- Research and Development
- FDA Regulations
- Standard Operating Procedures
- Product Development
- Engineering
- Strategy Development
- Quality Assurance
- Auditing
- Military Background
- Implementation
- Written Communication
- Education Experience
- Mentoring
- Documentation
- Employee Development
- Interpersonal Skills
- Reporting
- Collaboration
- Coaching
- Policy Development
- Filing
- Bachelor's Degree
- Regulations
- Project Management
- Problem Solving
- Microsoft Excel
- Teamwork
- Research Skills
- Time Management
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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