Manager of Regulatory Affairs Jobs in North Carolina
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.
A client of mine based in North Carolina are looking for a Regulatory CMC Executive Director that has strong, deep and proven expertise in biological and cell therapy products. The appropriate...
Site Name: USA - Pennsylvania - Upper Providence, Cambridge Park Drive, Durham Blackwell Street, Rockville Vaccines, Upper Merion, Waltham Posted Date: Mar 5 2025 Are you looking for a highly...
Fresenius Medical Care North America Mgr, Regulatory Affairs Pharma - HealthCanada in Raleigh , North Carolina PURPOSE AND SCOPE: Ensure overall (other than auditing responsibilities) regulatory...
Remote WorkSenior Regulatory Affairs Manager, Med Device Software (SaMD/SiMD)
- Raleigh, NC
- 30+ days ago
- Raleigh, NC
- 30+ days ago
Experience understanding, interpreting and applying regulations and standards (GxPs (GCPs, GLPs, GMPs), ISO 13485, IEC 62304). EU Medical Device Directive and EU Medical Device Regulation....
Regulatory Science Lead (Associate Director of Regulatory Affairs)
- Raleigh, NC
- 90+ days ago
- Raleigh, NC
- 90+ days ago
Make your mark for patients We are looking for a Regulatory Science Lead (Associate Director of Regulatory Affairs) who is a proactive, collaborative, and strategically minded individual to join...
Position at Kymanox I s Kymanox the right fit for you? You want to make a difference and have an impact You enjoy having an influence in your day-to-day work You are motivated by working alongside...
Director, Regulatory Affairs - Specialty (Infectious Disease, HIV)
- Durham, NC
- 90+ days ago
- Durham, NC
- 90+ days ago
Site Name: Durham Blackwell Street, USA - Pennsylvania - Upper Providence Posted Date: Nov 5 2024 Job Purpose Ensure the development of appropriate regional regulatory strategy(s) and their...
Demographic Data for North Carolina
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Salary for Manager of Regulatory Affairs Jobs in North Carolina
Required or preferred licenses and certifications for Manager of Regulatory Affairs positions.
Highest Education Level
Manager of Regulatory Affairss in North Carolina 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
- Biology
- Immunology
- Oncology
- Assay Development
- Medical Writing
- Drug Development
- Neuroscience
- Clinical Trials
- Drug Discovery
- Biotechnology
- Infectious Disease
- Pharmacovigilance
- Medical Affairs
- Gene Therapy
- Biomarkers
- Quality Systems
- Quality Management Systems
- 21 CFR 820
- GxP
- ICH Guidelines
- ISO 13485
- Change Control
- Good Clinical Practice
- Microbiology
- Medical Device Sales
- FDA Regulations
- Document Management
- Research and Development
- Resolution
- Standard Operating Procedures
- Engineering
- Product Development
- Strategy Development
- Quality Assurance
- Implementation
- Military Background
- Auditing
- Mentoring
- Written Communication
- Verbal Communication
- Documentation
- Collaboration
- Interpersonal Skills
- Reporting
- Education Experience
- Bachelor's Degree
- English
- Regulations
- Policy Development
- Project Management
- Microsoft Office
- Microsoft Excel
- Problem Solving
- Research Skills
- Staff Supervision
- Organization
- Leadership
- Communication Skills
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