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.
Associate Director, Regulatory Affairs US Lead, Regulatory Science & Execution
- AstraZeneca
- Gaithersburg, MD
- 14 hours ago
- Gaithersburg, 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 (5 miles from Gaithersburg, MD)
- 2 days ago
- Germantown, MD (5 miles from Gaithersburg, 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 Person- Goldbelt, Inc.
- Frederick, MD (23 miles from Gaithersburg, MD)
- 6 days ago
- Frederick, MD (23 miles from Gaithersburg, MD)
- 6 days ago
systems 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 PersonDirector, Regulatory Affairs & Payer Policy
- American Psychological Association
- Washington, DC (18 miles from Gaithersburg, MD)
- 8 days ago
- Washington, DC (18 miles from Gaithersburg, MD)
- 8 days ago
Note: APA operates on a 37.5-hour work week with one-hour lunch breaks each day. APA sets salaries based on several considerations, including years of relevant experience, level of education, and...
Remote- GreenBiz Group Inc.
- Washington, DC (18 miles from Gaithersburg, MD)
- 13 days ago
- Washington, DC (18 miles from Gaithersburg, MD)
- 13 days ago
Manager of Regulatory Affairs Washington, District of Columbia, United States About the job Job purpose Manage a portfolio of regulatory and policy issues related to EHS&S. Execute key program...
RemoteAssociate Regulatory Affairs Director, Spine
- IQVIA
- Washington, DC (18 miles from Gaithersburg, MD)
- 15 days ago
- Washington, DC (18 miles from Gaithersburg, MD)
- 15 days ago
Overview The Associate Director, Regulatory Affairs, Spine will be a critical team member supporting regulatory strategy and submissions for the firms clientele....
In PersonDirector, Regulatory Affairs Regenerative Medicine & Biologics Quality
- IQVIA
- Washington, DC (18 miles from Gaithersburg, MD)
- 16 days ago
- Washington, DC (18 miles from Gaithersburg, MD)
- 16 days ago
Overview The Director, Regulatory Affairs will be a critical team member supporting regulatory strategy and submissions for the firms clientele....
In PersonSenior Regulatory Affairs Director (Infectious Diseases)
- AstraZeneca
- Gaithersburg, MD
- 21 days ago
- Gaithersburg, 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 PersonRegulatory Affairs Manager or Sr. Manager
- National Hydropower Association
- Washington, DC (18 miles from Gaithersburg, MD)
- 24 days ago
- Washington, DC (18 miles from Gaithersburg, MD)
- 24 days ago
The National Hydropower Association (NHA) seeks a Policy Manager or Sr. Policy Manager to serve as a key member of our regulatory policy team, focusing on emerging policy issues that affect the...
In PersonProgram Manager, Regulatory Affairs
- Humane World for Animals
- Washington, DC (18 miles from Gaithersburg, MD)
- 27 days ago
- Washington, DC (18 miles from Gaithersburg, MD)
- 27 days ago
The general salary range for this full-time position is $70,000 - 105,000. Salary offers will be commensurate with experience, qualifications, skills, training and education. Humane World for...
Hybrid- Bausch + Lomb
- Reston, VA (15 miles from Gaithersburg, MD)
- 28 days ago
- Reston, VA (15 miles from Gaithersburg, MD)
- 28 days ago
The Director, Regulatory Affairs leads global regulatory strategy, reporting, compliance, labeling, and regulatory intelligence to support product development, approval, and market expansion....
In PersonDirector of Regulatory Affairs
- Blue Origin
- Arlington, VA (18 miles from Gaithersburg, MD)
- 30+ days ago
- Arlington, VA (18 miles from Gaithersburg, MD)
- 30+ days ago
Application close date: Applications will be accepted on an ongoing basis until the requisition is closed. At Blue Origin, we envision millions of people living and working in space for the...
In PersonRegulatory 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...
Hybrid- CTIA
- Washington, DC (18 miles from Gaithersburg, MD)
- 60+ days ago
- Washington, DC (18 miles from Gaithersburg, MD)
- 60+ days ago
Salary Range: $150,000 - $205,000 Summary: The Director, Regulatory Affairs works to advance the Regulatory Affairs Department's mission of promoting the wireless industry's positions on Federal regulatory...
HybridDirector of Regulatory Affairs, Satellite Policy
- Blue Origin
- Arlington, VA (18 miles from Gaithersburg, MD)
- 90+ days ago
- Arlington, VA (18 miles from Gaithersburg, MD)
- 90+ days ago
Blue Origin is seeking a Director, Regulatory Affairs to lead our policy advocacy strategy & execution....
In PersonDemographic Data for Gaithersburg, MD
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Salary for Director of Regulatory Affairs Jobs in Gaithersburg, MD
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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
- 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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