Director of Regulatory Affairs Jobs in Frederick, MD
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.
Associate Director, Regulatory Affairs US Lead, Regulatory Science & Execution
- AstraZeneca
- Gaithersburg, MD (23 miles from Frederick, MD)
- 14 hours ago
- Gaithersburg, MD (23 miles from Frederick, MD)
- 14 hours ago
The Associate Regulatory Affairs Director, US Lead, Regulatory Science & Execution will be accountable for the development, implementation and maintenance of regulatory strategies for assigned...
In PersonAssociate Director/Senior Manager Regulatory Affairs
- Precigen
- Germantown, MD (22 miles from Frederick, MD)
- 2 days ago
- Germantown, MD (22 miles from Frederick, MD)
- 2 days ago
POSITION SUMMARY: Based in Germantown, Maryland Precigen is seeking a highly motivated and experienced Associate Director/Senior Manager, Regulatory Affairs (level based on candidate experience)....
In Personsystems and procedures to ensure compliance with all applicable laws, regulations, and organizational quality standards in support of advanced development activities.* Conducts quality audits and oversight...
In PersonSenior Regulatory Affairs Director (Infectious Diseases)
- AstraZeneca
- Gaithersburg, MD (23 miles from Frederick, MD)
- 21 days ago
- Gaithersburg, MD (23 miles from Frederick, MD)
- 21 days ago
AstraZeneca - Infectious Diseases At AstraZeneca, we are committed to developing and delivering transformative vaccines and antibodies, providing long-lasting immunity for millions of people,...
In Person- AstraZeneca
- Gaithersburg, MD (23 miles from Frederick, MD)
- 30+ days ago
- Gaithersburg, MD (23 miles from Frederick, MD)
- 30+ days ago
Regulatory Affairs Director Oncology R&D Gaithersburg, MD Hybrid Work- on average 3 days a week from office The Regulatory Affairs Director (RAD) provides strategic and operational regulatory...
HybridDemographic Data for Frederick, MD
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Salary for Director of Regulatory Affairs Jobs in Frederick, MD
Required or preferred licenses and certifications for Director of Regulatory Affairs positions.
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Director of Regulatory Affairss in Frederick, MD offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Director of Regulatory Affairs position
- Clinical Research
- Biology
- Virology
- Immunology
- Oncology
- Medical Writing
- Drug Development
- Neuroscience
- Biostatistics
- Clinical Trials
- Drug Discovery
- Toxicology
- Biotechnology
- Pharmacovigilance
- Medical Affairs
- Gene Therapy
- ICH GCP
- Quality Management Systems
- 21 CFR 820
- ICH Guidelines
- Good Laboratory Practice
- ISO 13485
- Microbiology
- Document Management
- Research and Development
- Medical Device Sales
- FDA Regulations
- Standard Operating Procedures
- Product Development
- Analytical Skills
- Quality Assurance
- Engineering
- Strategy Development
- Auditing
- Process Improvement
- Documentation
- Coaching
- Mentoring
- Interpersonal Skills
- Writing Skills
- Implementation
- Verbal Communication
- Reporting
- Education Experience
- Collaboration
- Bachelor's Degree
- Regulations
- Research Skills
- Microsoft Office
- Project Management
- Problem Solving
- Staff Supervision
- Scheduling
- Teamwork
- Leadership
- Communication Skills
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