Manager of Regulatory Affairs Jobs in Washington, DC
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.
- Arlington, VA (3 miles from Washington, DC)
- 1 day ago
- Arlington, VA (3 miles from Washington, DC)
- 1 day ago
The Manager, Regulatory Affairs supports the Alliance's regulatory advocacy, outreach, and compliance assistance programs by tracking government regulatory activities, analyzing proposals and reports...
Government Relations, Regulatory Affairs Director, Tax Policy and Finance
- Arlington, VA (3 miles from Washington, DC)
- 6 days ago
- Arlington, VA (3 miles from Washington, DC)
- 6 days ago
Position Summary: This position is responsible for collaborating with professionals across NRECA's Government Relations Regulatory Unit, which is focused on electric cooperative advocacy before...
Associate Director, Regulatory Affairs (mRNA vaccines)
- Rockville, MD (14 miles from Washington, DC)
- 7 days ago
- Rockville, MD (14 miles from Washington, DC)
- 7 days ago
Site Name: USA - Pennsylvania - Upper Providence, Cambridge Park Drive, Durham Blackwell Street, Rockville Vaccines, Upper Merion, Waltham Posted Date: Mar 5 2025 Are you looking for a highly...
Senior Director, Regulatory Affairs
- Rockville, MD (14 miles from Washington, DC)
- 8 days ago
- Rockville, MD (14 miles from Washington, DC)
- 8 days ago
Advanced degrees (MA/MS/Ph.D.) are preferred.Knowledge of FDA regulations for biologics, including IND and BLA approvalsHands-on experience in global DMF filings and complianceUnderstands relevant industry...
Join Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared missionto serve patients living with serious illnessesdrives...
Director, Regulatory Affairs, Specialty
- Rockville, MD (14 miles from Washington, DC)
- 9 days ago
- Rockville, MD (14 miles from Washington, DC)
- 9 days ago
Site Name: USA - Pennsylvania - Upper Providence, Cambridge Park Drive, Collegeville TSA, USA - Maryland - Rockville Posted Date: Mar 3 2025 Job Purpose Ensure the development of appropriate...
Regulatory Affairs Director - Global Regulatory Lead
- Washington, DC
- 26 days ago
- Washington, DC
- 26 days ago
Join Amgens Mission of Serving Patients At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all...
Senior Policy and Regulatory Affairs Manager
- Washington, DC
- 30+ days ago
- Washington, DC
- 30+ days ago
The Policy and Regulatory Affairs team at Zoox is a cross-functional organization responsible for advancing Zoox's public policy and regulatory goals, including working with federal agencies such...
Remote WorkAssociate Director, Regulatory Affairs (In Vitro Diagnostics & Companion Diagnostics)
- Bethesda, MD (6 miles from Washington, DC)
- 60+ days ago
- Bethesda, MD (6 miles from Washington, DC)
- 60+ 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...
Associate Director, Regulatory Affairs (In Vitro Diagnostics & Companion Diagnostics)
- Washington, DC
- 60+ days ago
- Washington, DC
- 60+ 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...
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Salary for Manager of Regulatory Affairs Jobs in Washington, DC
Required or preferred licenses and certifications for Manager of Regulatory Affairs positions.
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Manager of Regulatory Affairss in Washington, DC 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
- Immunology
- Oncology
- Assay Development
- Medical Writing
- Drug Development
- Neuroscience
- Clinical Trials
- Drug Discovery
- Biotechnology
- Infectious Disease
- Pharmacovigilance
- Medical Affairs
- Gene Therapy
- Biomarkers
- Quality Systems
- Quality Management Systems
- 21 CFR 820
- GxP
- ICH Guidelines
- ISO 13485
- Change Control
- Good Clinical Practice
- Microbiology
- Medical Device Sales
- FDA Regulations
- Document Management
- Research and Development
- Resolution
- Standard Operating Procedures
- Engineering
- Product Development
- Strategy Development
- Quality Assurance
- Implementation
- Military Background
- Auditing
- Mentoring
- Written Communication
- Verbal Communication
- Documentation
- Collaboration
- Interpersonal Skills
- Reporting
- Education Experience
- Bachelor's Degree
- English
- Regulations
- Policy Development
- Project Management
- Microsoft Office
- Microsoft Excel
- Problem Solving
- Research Skills
- Staff Supervision
- Organization
- Leadership
- Communication Skills
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