Manager of Regulatory Affairs Jobs in Germantown, MD
A Manager of Regulatory Affairs in the quality control industry plays a pivotal role in ensuring that the company's products meet all necessary regulatory standards. Their key responsibilities include developing and implementing regulatory strategies, monitoring changes to regulatory guidelines, and ensuring the organization's compliance with these changes. They also engage in the preparation, review, and submission of regulatory documents to regulatory agencies. To effectively execute these responsibilities, they liaise with various stakeholders within and outside the organization, such as product developers, project managers, and regulatory bodies.
Important skills and certifications for a Manager of Regulatory Affairs include strong organizational and project management skills, excellent written and verbal communication skills, as well as a keen eye for detail. Analytical thinking and problem-solving skills are also crucial in this role. Additionally, they should possess relevant certifications such as the Regulatory Affairs Certification (RAC), which is recognized worldwide as the leading credential for regulatory professionals in the healthcare product sector. Before becoming a Manager of Regulatory Affairs, a person may have roles such as a Regulatory Affairs Specialist, Quality Control Analyst, or a Quality Assurance Associate. These roles would provide the necessary exposure and experience in quality control and regulatory affairs needed for the managerial position.
Associate Director, Regulatory Affairs US Lead, Regulatory Science & Execution
- AstraZeneca
- Gaithersburg, MD (5 miles from Germantown, MD)
- 8 hours ago
- Gaithersburg, MD (5 miles from Germantown, MD)
- 8 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
- 2 days ago
- Germantown, 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 (22 miles from Germantown, MD)
- 6 days ago
- Frederick, MD (22 miles from Germantown, 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 (21 miles from Germantown, MD)
- 8 days ago
- Washington, DC (21 miles from Germantown, 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 (21 miles from Germantown, MD)
- 13 days ago
- Washington, DC (21 miles from Germantown, 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....
RemoteAssociate Regulatory Affairs Director, Spine
- IQVIA
- Washington, DC (21 miles from Germantown, MD)
- 15 days ago
- Washington, DC (21 miles from Germantown, MD)
- 15 days ago
Responsibilities and Duties Develop and execute regulatory services for client companies, including however not limited to: Regulatory Submissions (e.g., 510(k), IDE, PMA, IND, BLA, & IND, Technical...
In PersonDirector, Regulatory Affairs Regenerative Medicine & Biologics Quality
- IQVIA
- Washington, DC (21 miles from Germantown, MD)
- 16 days ago
- Washington, DC (21 miles from Germantown, MD)
- 16 days ago
Responsibilities and Duties Develop and execute regulatory services for client companies, including however not limited to: Regulatory Submissions (e.g., IND, BLA, & pre-RFD, 510(k), IDE, PMA, Technical...
In PersonSenior Regulatory Affairs Director (Infectious Diseases)
- AstraZeneca
- Gaithersburg, MD (5 miles from Germantown, MD)
- 21 days ago
- Gaithersburg, MD (5 miles from Germantown, 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 (21 miles from Germantown, MD)
- 24 days ago
- Washington, DC (21 miles from Germantown, 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 (21 miles from Germantown, MD)
- 27 days ago
- Washington, DC (21 miles from Germantown, MD)
- 27 days ago
Humane World for Animals, a global leader in animal advocacy and protection, is seeking a Program Manager, Regulatory, Federal Affairs....
Hybrid- Bausch + Lomb
- Reston, VA (12 miles from Germantown, MD)
- 28 days ago
- Reston, VA (12 miles from Germantown, MD)
- 28 days ago
Bausch + Lomb (NYSE/TSX: BLCO) is a leading global eye health company dedicated to protecting and enhancing the gift of sight for millions of people around the worldfrom the moment of birth...
In PersonDirector of Regulatory Affairs
- Blue Origin
- Arlington, VA (20 miles from Germantown, MD)
- 30+ days ago
- Arlington, VA (20 miles from Germantown, 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 Person- AstraZeneca
- Gaithersburg, MD (5 miles from Germantown, MD)
- 30+ days ago
- Gaithersburg, MD (5 miles from Germantown, 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...
Hybrid- CTIA
- Washington, DC (21 miles from Germantown, MD)
- 60+ days ago
- Washington, DC (21 miles from Germantown, 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...
HybridDirector of Regulatory Affairs, Satellite Policy
- Blue Origin
- Arlington, VA (20 miles from Germantown, MD)
- 90+ days ago
- Arlington, VA (20 miles from Germantown, MD)
- 90+ 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 PersonDemographic Data for Germantown, MD
Moving to Germantown, MD? Find some basic demographic data about Germantown, MD below.
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Salary for Manager of Regulatory Affairs Jobs in Germantown, MD
Required or preferred licenses and certifications for Manager of Regulatory Affairs positions.
Highest Education Level
Manager of Regulatory Affairss in Germantown, MD offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Manager 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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