Director of Regulatory Affairs Jobs in Gaithersburg, 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.
Senior Director of Regulatory Affairs
- Washington, DC (18 miles from Gaithersburg, MD)
- 4 hours ago
- Washington, DC (18 miles from Gaithersburg, MD)
- 4 hours ago
Senior Director of Regulatory Affairs at SecurityScorecard Remote (USA) About SecurityScorecard: SecurityScorecard is the global leader in cybersecurity ratings, with over 12 million companies continuously...
- Washington, DC (18 miles from Gaithersburg, MD)
- 1 day ago
- Washington, DC (18 miles from Gaithersburg, MD)
- 1 day ago
District of Columbia, United States of America Job Family Group: Legal Jobs Worker Type: Regular Posting Start Date: June 13, 2025 Business unit: Trading and Supply Experience Level: Experienced...
Associate Director, Regulatory Affairs - Cmc (Cell Therapy)
- Gaithersburg, MD
- 3 days ago
- Gaithersburg, MD
- 3 days ago
The Associate Director, Regulatory Affairs, CMC - Cell & Gene Therapies (CGT) supports the development and successful performance of the CMC regulatory strategy for the innovative pipeline of Cell &...
Regulatory Affairs Director, Emergency Management and Safety
- Arlington, VA (18 miles from Gaithersburg, MD)
- 3 days ago
- Arlington, VA (18 miles from Gaithersburg, MD)
- 3 days ago
Position Summary: The National Rural Electric Cooperative Association (NRECA) is the national trade association representing 900 not-for-profit electric cooperatives and other rural electric...
Director, Regulatory Affairs, Regulatory Science & Execution
- Gaithersburg, MD
- 15 days ago
- Gaithersburg, MD
- 15 days ago
This is what you will do: The Regulatory Affairs Director (RAD), Regulatory Science & Execution will be accountable for the development, implementation and maintenance of regulatory strategies for...
Diagnostic Regulatory Affairs Manager
- Washington, DC (18 miles from Gaithersburg, MD)
- 22 days ago
- Washington, DC (18 miles from Gaithersburg, MD)
- 22 days ago
HOW MIGHT YOU DEFY IMAGINATION? Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and...
AstraZeneca - Vaccines & Immune Therapies At AstraZeneca, we are committed to developing and delivering transformative vaccines and antibodies, providing long-lasting immunity for millions of...
AstraZeneca - Vaccines & Immune Therapies At AstraZeneca, we are committed to developing and delivering transformative vaccines and antibodies, providing long-lasting immunity for millions of...
Director, Regulatory Affairs - CMC (Cell Therapy)
- Gaithersburg, MD
- 30+ days ago
- Gaithersburg, MD
- 30+ days ago
This position may be based in Santa Monica, CA or Gaithersburg, M D and reports to the Senior Director, CMC Regulatory Affairs (CGT)....
- Frederick, MD (23 miles from Gaithersburg, MD)
- 45+ days ago
- Frederick, MD (23 miles from Gaithersburg, MD)
- 45+ days ago
Systems, and import/export requirements Experience as the RA representative on project core teams Strong communication and teamwork skills Ability to lead multiple projects and meet deadlines Capacity...
Associate Director, Regulatory Affairs (In Vitro Diagnostics & Companion Diagnostics)
- Bethesda, MD (11 miles from Gaithersburg, MD)
- 90+ days ago
- Bethesda, MD (11 miles from Gaithersburg, MD)
- 90+ days ago
Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely...
Demographic Data for Gaithersburg, MD
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Salary for Director of Regulatory Affairs Jobs in Gaithersburg, MD
Required or preferred licenses and certifications for Director of Regulatory Affairs positions.
Highest Education Level
Director of Regulatory Affairss in Gaithersburg, 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
- Biochemistry
- Biology
- Immunology
- Assay Development
- Medical Writing
- Scientific Writing
- Drug Development
- Clinical Trials
- Toxicology
- Biotechnology
- Next-Generation Sequencing
- Pharmacovigilance
- Medical Affairs
- Gene Therapy
- ICH GCP
- Internal Audits
- Quality Management Systems
- Quality Systems
- Supplier Auditing
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- GxP
- Medical Device Sales
- Microbiology
- Document Management
- FDA Regulations
- Research and Development
- Complaint Resolution
- Resolution
- Standard Operating Procedures
- Product Development
- Engineering
- Strategy Development
- Process Improvement
- Quality Assurance
- Implementation
- Auditing
- Verbal Communication
- Written Communication
- Mentoring
- Collaboration
- Documentation
- Coaching
- Interpersonal Skills
- Reporting
- Bachelor's Degree
- Filing
- Regulations
- Policy Development
- Project Management
- Problem Solving
- Microsoft Excel
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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