Regulatory Affairs Managers
Business, Management and AdministrationO*NET 11-9199.01United States
Plan, direct, or coordinate production activities of an organization to ensure compliance with regulations and standard operating procedures.
- Median annual earnings
- $106,813
- Projected change
- +8.9%
- Typical education
- Bachelor's degree
- Employment
- 1.14M jobs
50th percentile, United States
2025 to 2035
78.3% of the workforce
Growing to 1.24M by 2035
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The work
What regulatory affairs managers do
Tasks reported for this occupation, ordered by how often they come up in the role.
- Develop regulatory strategies and implementation plans for the preparation and submission of new products.
- Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards.
- Direct the preparation and submission of regulatory agency applications, reports, or correspondence.
- Investigate product complaints and prepare documentation and submissions to appropriate regulatory agencies as necessary.
- 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.
- Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.
- Manage activities such as audits, regulatory agency inspections, or product recalls.
- Communicate regulatory information to multiple departments and ensure that information is interpreted correctly.
- Maintain current knowledge of relevant regulations, including proposed and final rules.
- Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.
- Direct documentation efforts to ensure compliance with domestic and international regulations and standards.
- Review materials such as marketing literature or user manuals to ensure that regulatory agency requirements are met.
- Participate in the development or implementation of clinical trial protocols.
- Implement or monitor complaint processing systems to ensure effective and timely resolution of all complaint investigations.
- Establish procedures or systems for publishing document submissions in hardcopy or electronic formats.
- Establish regulatory priorities or budgets and allocate resources and workloads.
- Train staff in regulatory policies or procedures.
- Develop and maintain standard operating procedures or local working practices.
- Monitor regulatory affairs activities to ensure their alignment with corporate sustainability or green initiatives.
- Contribute to the development or implementation of business unit strategic and operating plans.
- Coordinate internal discoveries and depositions with legal department staff.
- Monitor emerging trends regarding industry regulations to determine potential impacts on organizational processes.
- Develop relationships with state or federal environmental regulatory agencies to learn about and analyze the potential impacts of proposed environmental policy regulations.
- Monitor regulatory affairs trends related to environmental issues.
- Evaluate regulatory affairs aspects that are specifically green, such as the use of toxic substances in packaging, carbon footprinting issues, or green policy implementation.
Pay and outlook
What the job pays and where it is heading
Annual earnings range
Reported earnings by percentile, United States
- 10th percentile
- $49,585
- 25th percentile
- $73,342
- 50th percentile
- $106,813
- 75th percentile
- $152,210
- 90th percentile
- $237,454
The gold marker shows the median. Half earn more than $106,813 and half earn less.
Employment outlook
2025 to 2035 projection
+8.9%faster than average
20251,136,396 jobs
2035 projected1,237,142 jobs
100,746 more positions over the decade, before replacement hiring.
Preparation
Education levels
What people currently working in the career hold. These are not entry requirements.
- Bachelor's degree
- 78.3%
- Master's or Professional degree
- 13%
- Some college
- 4.4%
- Doctoral degree or more
- 4.4%
Skills
Skills employers ask for
Technical skills appearing most often in job postings for this occupation.
How the work gets done
Core competencies
Broad capabilities associated with strong performance in this occupation.
- Writing
- Communicating effectively in writing as appropriate for the needs of the audience.
- Reading Comprehension
- Understanding written sentences and paragraphs in work-related documents.
- Speaking
- Talking to others to convey information effectively.
- Active Listening
- Giving full attention to what other people are saying, taking time to understand the points being made, asking questions as appropriate, and not interrupting at inappropriate times.
- Critical Thinking
- Using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions, or approaches to problems.
- Judgment and Decision Making
- Considering the relative costs and benefits of potential actions to choose the most appropriate one.
- Systems Analysis
- Determining how a system should work and how changes in conditions, operations, and the environment will affect outcomes.
- Systems Evaluation
- Identifying measures or indicators of system performance and the actions needed to improve or correct performance, relative to the goals of the system.
- Complex Problem Solving
- Identifying complex problems and reviewing related information to develop and evaluate options and implement solutions.
- Monitoring
- Monitoring/Assessing performance of yourself, other individuals, or organizations to make improvements or take corrective action.
- Time Management
- Managing one's own time and the time of others.
- Active Learning
- Understanding the implications of new information for both current and future problem-solving and decision-making.
- Coordination
- Adjusting actions in relation to others' actions.
- Social Perceptiveness
- Being aware of others' reactions and understanding why they react as they do.
- Instructing
- Teaching others how to do something.
- Management of Personnel Resources
- Motivating, developing, and directing people as they work, identifying the best people for the job.
- Learning Strategies
- Selecting and using training/instructional methods and procedures appropriate for the situation when learning or teaching new things.
- Negotiation
- Bringing others together and trying to reconcile differences.
- Persuasion
- Persuading others to change their minds or behavior.
- Service Orientation
- Actively looking for ways to help people.
In the market
Job titles and employers
Recent job postings in United StatesCommon job titles
- 01Regulatory Affairs Managers999 postings
- 02Directors of Regulatory Affairs995 postings
- 03Regulatory Affairs Consultants479 postings
- 04CMC Regulatory Affairs Managers284 postings
- 05Global Regulatory Affairs Managers237 postings
- 06Directors of Global Regulatory Affairs198 postings
- 07Regulatory Managers186 postings
- 08Associate Directors of Regulatory Affairs184 postings
- 09Global Regulatory Leads145 postings
- 10Directors of Advertising and Promotions120 postings
- 11Regulatory Affairs Associates105 postings
- 12Regulatory Labeling Specialists66 postings
- 13Promotional Advertising Assistants58 postings
- 14Vice Presidents of Regulatory Affairs45 postings
- 15Vaccines Account Managers42 postings
- 16Heads of Regulatory Affairs39 postings
- 17Regulatory Affairs Project Managers36 postings
- 18Regulatory Directors34 postings
- 19Medical Affairs Managers31 postings
- 20Regulatory Specialists30 postings
Top employers
- 01Parexel567 postings
- 02Bausch Health402 postings
- 03Otsuka America271 postings
- 04Sumitomo Pharma105 postings
- 05Takeda Pharmaceutical Company96 postings
- 06AbbVie88 postings
- 07McKesson84 postings
- 08Amgen70 postings
- 09Sanofi61 postings
- 10Cardinal Health58 postings
- 11GlaxoSmithKline57 postings
- 12Proclinical Staffing57 postings
- 13inVentiv Health48 postings
- 14Pfizer47 postings
- 15Actalent43 postings
- 16Fresenius43 postings
- 17Meet Life Sciences37 postings
- 18Thermo Fisher Scientific34 postings
- 19Dennis Partners30 postings
- 20Katalyst Healthcares & Life Sciences30 postings
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