Manager of Regulatory Affairs Jobs in North Wales, PA
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.
Manager, Regulatory Affairs, CMC Vaccines
- Collegeville, PA (9 miles from North Wales, PA)
- 11 hours ago
- Collegeville, PA (9 miles from North Wales, PA)
- 11 hours ago
Site Name: Belgium-Wavre, GSK HQ, India - Karnataka - Vemgal Bangalore Site, Italy - Siena, Poznan Business Garden, Rixensart, UK - Hertfordshire - Stevenage, USA - Maryland - Rockville, USA -...
Senior Manager, Regulatory Affairs
- Philadelphia, PA (17 miles from North Wales, PA)
- 1 day ago
- Philadelphia, PA (17 miles from North Wales, PA)
- 1 day ago
Senior Manager, Regulatory Affairs JOB DETAILS REQ ID:R010528 LOCATION:Philadelphia, PA -- [Remote/Home-Based] CATEGORY:Research & Development If you are a current Jazz employee please apply via the...
Senior Director, Regulatory Affairs
- Philadelphia, PA (17 miles from North Wales, PA)
- 1 day ago
- Philadelphia, PA (17 miles from North Wales, PA)
- 1 day ago
This position is responsible for building the regulatory team at Context Therapeutics. The Senior Director of Regulatory Affairs will define and implement innovative regulatory strategies that...
Associate Director, Regulatory Affairs - Labeling Management
- North Wales, PA
- 7 days ago
- North Wales, PA
- 7 days ago
Regulations, Management Process, Pharmacovigilance, Policy Implementation, Regulatory Affairs Compliance, Regulatory Compliance, Regulatory Labeling, Regulatory Operations, Regulatory Submissions,...
Associate Director, Regulatory Affairs CMC
- Radnor, PA (12 miles from North Wales, PA)
- 9 days ago
- Radnor, PA (12 miles from North Wales, PA)
- 9 days ago
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 (9 miles from North Wales, PA)
- 12 days ago
- Collegeville, PA (9 miles from North Wales, PA)
- 12 days ago
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
- Collegeville, PA (9 miles from North Wales, PA)
- 17 days ago
- Collegeville, PA (9 miles from North Wales, PA)
- 17 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...
Director, Regulatory Affairs - Dossier Project Manager
- West Chester, PA (24 miles from North Wales, PA)
- 30+ days ago
- West Chester, PA (24 miles from North Wales, 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...
- Philadelphia, PA (17 miles from North Wales, PA)
- 45+ days ago
- Philadelphia, PA (17 miles from North Wales, PA)
- 45+ 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...
Demographic Data for North Wales, PA
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Salary for Manager of Regulatory Affairs Jobs in North Wales, PA
Required or preferred licenses and certifications for Manager of Regulatory Affairs positions.
Highest Education Level
Manager of Regulatory Affairss in North Wales, PA 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
- Scientific Writing
- Drug Development
- Clinical Trials
- 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
- Microbiology
- Product Launch
- Document Management
- Medical Device Sales
- Research and Development
- FDA Regulations
- Standard Operating Procedures
- Product Development
- Engineering
- Strategy Development
- Quality Assurance
- Auditing
- Military Background
- Implementation
- Written Communication
- Education Experience
- Mentoring
- Verbal Communication
- Documentation
- Employee Development
- Reporting
- Coaching
- Collaboration
- Interpersonal Skills
- Filing
- Bachelor's Degree
- Policy Development
- Regulations
- Project Management
- Problem Solving
- Research Skills
- Time Management
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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