Director of Regulatory Affairs Jobs in Raleigh, NC
The Director of Regulatory Affairs in the quality control industry plays an essential role in ensuring that the company's products meet all regulatory standards and compliance requirements. This individual oversees the development and implementation of regulatory strategies for new and existing products, supervises the preparation of regulatory submissions, and maintains communication with regulatory authorities. They also monitor changes in regulations, interpret these updates for relevant departments within the company, and implement necessary changes to maintain compliance. They are responsible for setting the company's standards for quality, safety, and efficacy.
To excel in this role, one should possess excellent analytical skills, strategic thinking, and strong leadership abilities. A deep understanding of regulatory guidelines, ability to interpret complex regulations, and excellent communication skills are essential. They should have a degree in a relevant field, along with certifications such as Regulatory Affairs Certification (RAC), Certified Quality Auditor (CQA), and Certified Quality Engineer (CQE). Prior to becoming a Director of Regulatory Affairs, individuals might have roles such as Regulatory Affairs Specialist, Regulatory Affairs Manager, or Quality Control Manager.
- Morrisville, NC (11 miles from Raleigh, NC)
- 3 days ago
- Morrisville, NC (11 miles from Raleigh, NC)
- 3 days ago
Solid understanding of Design Control requirements, FDA QSR regulations, and ISO 13485 MDSAP quality System Management Keen ability to prioritize work and execute in an environment of competing priorities...
Business Operations Manager: Regulatory Affairs
- Durham, NC (21 miles from Raleigh, NC)
- 13 days ago
- Durham, NC (21 miles from Raleigh, NC)
- 13 days ago
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...
Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe...
Director, Regulatory Affairs - Specialty (Infectious Disease, HIV)
- Durham, NC (21 miles from Raleigh, NC)
- 45+ days ago
- Durham, NC (21 miles from Raleigh, 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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Salary for Director of Regulatory Affairs Jobs in Raleigh, NC
Required or preferred licenses and certifications for Director of Regulatory Affairs positions.
Highest Education Level
Director of Regulatory Affairss in Raleigh, NC offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Director 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
- Gene Therapy
- Biomarkers
- Internal Audits
- Quality Management Systems
- Quality Systems
- 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
- Coaching
- Bachelor's Degree
- Regulations
- Project Management
- Problem Solving
- Microsoft Excel
- Research Skills
- Staff Supervision
- Organization
- Leadership
- Communication Skills
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