Director of Regulatory Affairs Jobs in Durham, 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.
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...
Senior Manager, Regulatory Affairs
- Raleigh, NC (21 miles from Durham, NC)
- 4 days ago
- Raleigh, NC (21 miles from Durham, NC)
- 4 days ago
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...
- Cary, NC (17 miles from Durham, NC)
- 5 days ago
- Cary, NC (17 miles from Durham, NC)
- 5 days ago
Verdesian Life Sciences is in search of an individual to fill the role of Regulatory Affairs Manager in the corporate office in Cary, North Carolina. Individual should already reside in the...
Business Operations Manager: Regulatory Affairs
- Rtp, NC (6 miles from Durham, NC)
- 5 days ago
- Rtp, NC (6 miles from Durham, NC)
- 5 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
- 30+ days ago
- Durham, NC
- 30+ 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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Director 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 Director of Regulatory Affairs position
- Medical Terminology
- Clinical Research
- Biology
- Immunology
- Oncology
- Assay Development
- Neurology
- Medical Writing
- Drug Development
- Clinical Trials
- Drug Discovery
- Biotechnology
- Next-Generation Sequencing
- Pharmacovigilance
- Gene Therapy
- Biomarkers
- Internal Audits
- Quality Systems
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Change Control
- Medical Device Sales
- FDA Regulations
- Document Management
- Research and Development
- Resolution
- Product Development
- Engineering
- Strategy Development
- Quality Assurance
- Military Background
- Implementation
- 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
- Scheduling
- Leadership
- Communication Skills
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