Regulatory Affairs Managers
Plan, direct, or coordinate production activities of an organization to ensure compliance with regulations and standard operating procedures.
Also known as: CMC Director (Chemistry, Manufacturing, and Controls Director), CMC Regulatory Affairs Manager (Chemistry, Manufacturing and Controls Regulatory Affairs Manager), Compliance Director, Global RA Director (Global Regulatory Affairs Director), Global RA Manager (Global Regulatory Affairs Manager), International Regulatory Affairs Specialist, RA and Compliance Director (Regulatory Affairs and Compliance Director), RA Director (Regulatory Affairs Director), ...
Annual Salary
Median annual wage (May 2024)
Job Outlook
Projected growth, 2024–2034 (Faster than average)
What You'd Do
- Direct the preparation and submission of regulatory agency applications, reports, or correspondence.
- Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.
- Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.
- Communicate regulatory information to multiple departments and ensure that information is interpreted correctly.
- Develop regulatory strategies and implementation plans for the preparation and submission of new products.
- Establish regulatory priorities or budgets and allocate resources and workloads.
- Implement or monitor complaint processing systems to ensure effective and timely resolution of all complaint investigations.
- Investigate product complaints and prepare documentation and submissions to appropriate regulatory agencies as necessary.
- Maintain current knowledge of relevant regulations, including proposed and final rules.
- Manage activities such as audits, regulatory agency inspections, or product recalls.
- Monitor emerging trends regarding industry regulations to determine potential impacts on organizational processes.
- Participate in the development or implementation of clinical trial protocols.
- Provide responses to regulatory agencies regarding product information or issues.
- Represent organizations before domestic or international regulatory agencies on major policy matters or decisions regarding company products.
- Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards.
- Review materials such as marketing literature or user manuals to ensure that regulatory agency requirements are met.
- Train staff in regulatory policies or procedures.
- Contribute to the development or implementation of business unit strategic and operating plans.
- Coordinate internal discoveries and depositions with legal department staff.
- Develop and maintain standard operating procedures or local working practices.
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
Is Regulatory Affairs Managers right for you?
Take our free career quiz to see how you match with this and 900+ other careers.
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.