Regulatory Affairs Specialists

Education and TrainingO*NET 13-1041.07United States

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.

COMING SOON See related ASU learning

Median annual earnings: $80,590
Projected change: +6.7%
Typical education: Bachelor's degree
Employment: 435.38K jobs

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Build the skills

ASU learning related to this career

These courses and certificates are connected through catalog career relationships and Lightcast skill tags.

The work

What regulatory affairs specialists do

Tasks reported for this occupation, ordered by how often they come up in the role.

Coordinate efforts associated with the preparation of regulatory documents or submissions.
Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.
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.
Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes.
Prepare or maintain technical files as necessary to obtain and sustain product approval.
Coordinate recall or market withdrawal activities as necessary.
Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.
Review adverse drug reactions and file all related reports in accordance with regulatory agency guidelines.
Identify relevant guidance documents, international standards, or consensus standards.
Provide technical review of data or reports to be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
Provide pre-, ongoing, and post-inspection follow-up assistance to governmental inspectors.
Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
Review clinical protocols to ensure collection of data needed for regulatory submissions.
Recommend changes to company procedures in response to changes in regulations or standards.
Compile and maintain regulatory documentation databases or systems.
Participate in internal or external audits.
Write or update standard operating procedures, work instructions, or policies.
Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards.
Develop or track quality metrics.
Develop or conduct employee regulatory training.
Recommend adjudication of product complaints.

Pay and outlook

What the job pays and where it is heading

Annual earnings range

Reported earnings by percentile, United States

10th percentile: $48,005
25th percentile: $61,129
50th percentile: $80,590
75th percentile: $109,168
90th percentile: $134,126

The gold marker shows the median. Half earn more than $80,590 and half earn less.

Employment outlook

2025 to 2035 projection

+6.7%faster than average

2025435,376 jobs

2035 projected464,669 jobs

29,293 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: 85%
Master's or Professional degree: 10%
Doctoral degree or more: 5%

Skills

Skills employers ask for

Technical skills appearing most often in job postings for this occupation.

Regulatory Affairs
Medical Devices
Pharmaceuticals
New Product Development
Packaging And Labeling
Regulatory Compliance
Auditing
Regulatory Documents
Chemistry
Project Management
Product Registration
Marketing
Biology
Life Sciences
Technical Writing
Biotechnology
Regulatory Intelligence
Quality Management Systems
Clinical Trials
Lifecycle Management

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.
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.
Reading Comprehension: Understanding written sentences and paragraphs in work-related documents.
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.
Complex Problem Solving: Identifying complex problems and reviewing related information to develop and evaluate options and implement solutions.
Time Management: Managing one's own time and the time of others.
Social Perceptiveness: Being aware of others' reactions and understanding why they react as they do.
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.
Active Learning: Understanding the implications of new information for both current and future problem-solving and decision-making.
Monitoring: Monitoring/Assessing performance of yourself, other individuals, or organizations to make improvements or take corrective action.
Coordination: Adjusting actions in relation to others' actions.
Negotiation: Bringing others together and trying to reconcile differences.
Persuasion: Persuading others to change their minds or behavior.
Instructing: Teaching others how to do something.
Service Orientation: Actively looking for ways to help people.
Learning Strategies: Selecting and using training/instructional methods and procedures appropriate for the situation when learning or teaching new things.
Management of Personnel Resources: Motivating, developing, and directing people as they work, identifying the best people for the job.

In the market

Job titles and employers

Recent job postings in United States

Common job titles

01Regulatory Affairs Specialists1,714 postings
02Regulatory Specialists340 postings
03Regulatory Affairs Associates332 postings
04Regulatory Affairs Consultants262 postings
05Associate Directors of Regulatory Affairs117 postings
06Scientists116 postings
07Regulatory Affairs Scientists100 postings
08Regulatory Labeling Specialists82 postings
09Regulatory Scientists70 postings
10Regulatory Consultants60 postings
11Combo Drivers57 postings
12Labeling Associates54 postings
13Regulatory Affairs Interns53 postings
14Regulatory Coordinators53 postings
15Regulatory Affairs Coordinators51 postings
16Regulatory Engineers46 postings
17International Regulatory Affairs Specialists39 postings
18Regulatory Affairs Analysts37 postings
19Regulatory Managers35 postings
20Directors of Regulatory Affairs34 postings

Top employers

01Cardinal Health476 postings
02Parexel276 postings
03Actalent154 postings
04Merck & Co.142 postings
05Otsuka America106 postings
06inVentiv Health99 postings
07Henry Schein82 postings
08Abbott Laboratories71 postings
09Fujifilm57 postings
10Medtronic56 postings
11ManpowerGroup52 postings
12Grail47 postings
13Boston Scientific39 postings
14BD34 postings
15Kelly Services27 postings
16Insight Global25 postings
17Collabera24 postings
18Constellation Energy24 postings
19Katalyst Healthcares & Life Sciences23 postings
20Koninklijke Philips N.V23 postings

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