Manager of Regulatory Affairs Jobs in Durham, NC
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.
Business Operations Manager: Regulatory Affairs 4.1 4.1 out of 5 stars Research Triangle Park, NC The application window is expected to close on: 4.29.2025 Job posting may be removed earlier if the...
Senior Manager, Regulatory Affairs
- Raleigh, NC (21 miles from Durham, NC)
- 10 days ago
- Raleigh, NC (21 miles from Durham, NC)
- 10 days ago
**Job Overview** We are currently seeking a dynamic, highly motivated, and experienced individual for the position of **Senior Manager, Regulatory Affairs**....
Business Operations Manager: Regulatory Affairs
- Rtp, NC (6 miles from Durham, NC)
- 11 days ago
- Rtp, NC (6 miles from Durham, NC)
- 11 days ago
The application window is expected to close on: 4.29.2025 Job posting may be removed earlier if the position is filled or if a sufficient number of applications are received. This is a remote...
Director, Regulatory Affairs - Specialty (Infectious Disease, HIV)
- Durham, NC
- 45+ days ago
- Durham, NC
- 45+ days ago
Site Name: Durham Blackwell Street, USA - Pennsylvania - Upper Providence Posted Date: Mar 20 2025 Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global...
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Required or preferred licenses and certifications for Manager of Regulatory Affairs positions.
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Manager of Regulatory Affairss in Durham, NC offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Manager of Regulatory Affairs position
- Medical Terminology
- Clinical Research
- Biology
- Immunology
- Oncology
- Assay Development
- Neurology
- Drug Development
- Clinical Trials
- Drug Discovery
- Biotechnology
- Next-Generation Sequencing
- Pharmacovigilance
- Medical Affairs
- Gene Therapy
- Biomarkers
- Internal Audits
- Quality Systems
- Quality Management Systems
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Change Control
- Medical Device Sales
- FDA Regulations
- Document Management
- Research and Development
- Resolution
- Standard Operating Procedures
- Product Development
- Engineering
- Strategy Development
- Quality Assurance
- Military Background
- Implementation
- Auditing
- Investigation
- Written Communication
- Verbal Communication
- Documentation
- Mentoring
- Collaboration
- Interpersonal Skills
- Reporting
- Education Experience
- Bachelor's Degree
- Coaching
- Regulations
- Project Management
- Problem Solving
- Microsoft Excel
- Research Skills
- Staff Supervision
- Organization
- Leadership
- Communication Skills
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