Regulatory Affairs Specialists
Coordinate and document internal regulatory processes, such as internal audits, inspections, license renewals, or registrations. May compile and prepare materials for submission to regulatory agencies.
Also known as: Anti Money Laundering Compliance Analyst (AML Compliance Analyst), Clinical Quality Assurance Associate, Clinical Quality Assurance Specialist, CMC Regulatory Affairs Manager (Chemistry, Manufacturing, and Controls Regulatory Affairs Manager), Drug Regulatory Affairs Specialist, Product Safety Specialist, Product Stewardship Specialist, Quality Assurance Documentation Coordinator, ...
Annual Salary
Median annual wage (May 2024)
Job Outlook
Projected growth, 2024–2034 (About average)
What You'd Do
- Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
- Coordinate, prepare, or review regulatory submissions for domestic or international projects.
- Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.
- Provide technical review of data or reports to be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
- Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.
- Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
- Compile and maintain regulatory documentation databases or systems.
- Coordinate efforts associated with the preparation of regulatory documents or submissions.
- Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes.
- Develop or conduct employee regulatory training.
- Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
- Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards.
- Participate in internal or external audits.
- Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.
- Prepare or maintain technical files as necessary to obtain and sustain product approval.
- Recommend changes to company procedures in response to changes in regulations or standards.
- Review clinical protocols to ensure collection of data needed for regulatory submissions.
- Write or update standard operating procedures, work instructions, or policies.
- Coordinate recall or market withdrawal activities as necessary.
- Develop or track quality metrics.
Top Skills
Importance scale: 1 (low) – 5 (high)
Knowledge Areas
Importance scale: 1 (low) – 5 (high)
Education Level Distribution
Percentage of workers in this occupation by education level
Technology & Tools
Software and tools commonly used in this role
In-Demand Technologies
Other Tools
Work Styles
Personality traits and work styles important for this career
Key Abilities
Cognitive, physical, and sensory abilities important for this role
Importance scale: 1 (low) – 5 (high)
Work Activities
General types of job behaviors occurring on this job
Importance scale: 1 (low) – 5 (high)
Work Environment
Physical and social factors that influence the nature of work
Related Careers
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Salary data: BLS Occupational Employment and Wage Statistics, May 2024. Outlook data: BLS Employment Projections, 2024–2034.
This page includes information from the O*NET 30.2 Database by the U.S. Department of Labor, Employment and Training Administration (USDOL/ETA). Used under the CC BY 4.0 license.