Regulatory Affairs Specialist job description: duties, skills and qualifications.

Core duties

16

O*NET task statements

Preparation

Job Zone 4 of 5

considerable preparation

Typical entry education

Bachelor's degree

BLS 2025–35 · broader occupation

Median pay

$80,730

BLS May 2025 · broader occupation

1. Coordinate, prepare, or review regulatory submissions for domestic or international projects. importance 4.8 of 5
2. Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review. importance 4.7 of 5
3. Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents. importance 4.7 of 5
4. Review adverse drug reactions and file all related reports in accordance with regulatory agency guidelines. importance 4.6 of 5
5. Coordinate efforts associated with the preparation of regulatory documents or submissions. importance 4.6 of 5
6. Prepare or direct the preparation of additional information or responses as requested by regulatory agencies. importance 4.6 of 5
7. Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes. importance 4.5 of 5
8. Prepare or maintain technical files as necessary to obtain and sustain product approval. importance 4.4 of 5
9. Coordinate recall or market withdrawal activities as necessary. importance 4.4 of 5
10. Provide pre-, ongoing, and post-inspection follow-up assistance to governmental inspectors. importance 4.3 of 5
11. Develop regulatory strategies for products. importance 4.3 of 5
12. Identify relevant guidance documents, international standards, or consensus standards. importance 4.3 of 5
13. Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues. importance 4.3 of 5
14. Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures. importance 4.3 of 5
15. Provide technical review of data or reports to be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation. importance 4.2 of 5
16. Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies. importance 4.2 of 5

Work activities O*NET rates most important here: Evaluating Information to Determine Compliance with Standards, Getting Information, Updating and Using Relevant Knowledge, Working with Computers and Making Decisions and Solving Problems.

Also part of the job

Supplemental tasks O*NET lists for this occupation: less central than the core duties above, and not done in every job.

• Recommend adjudication of product complaints.
• Determine the legal implications of the production, supply, or use of ozone-depleting substances or equipment containing such substances.
• Determine requirements applying to treatment, storage, shipment, or disposal of potentially hazardous production-related waste.
• Determine regulations or procedures related to the management, collection, reuse, recovery, or recycling of packaging waste.
• Direct the collection and preparation of laboratory samples as requested by regulatory agencies.

Knowledge areas: English Language, Law and Government, Administration and Management, Administrative and Computers and Electronics.

Software O*NET lists for this occupation: Microsoft Excel, Microsoft Office software, Microsoft Outlook, Microsoft PowerPoint, Microsoft Word, Microsoft Visio. These are examples O*NET records for the job, not a list of tools every employer uses or a checklist of what you must know.

• Education: BLS lists a bachelor's degree as the typical entry-level education for the broader occupation.
• Experience: BLS lists no work experience in a related occupation as typical to enter.
• Training on the job: BLS lists moderate-term on-the-job training as typical once hired.
• Preparation: O*NET places the job in Job Zone 4 of 5 (considerable preparation). A considerable amount of work-related skill, knowledge, or experience is needed for these occupations.
• Licenses and certifications: not listed here. A license is a legal requirement set by a state; a certification is a credential from a private or professional body. Rules vary by state and employer, and a missing entry on this page does not mean none is required: check with your state's licensing board and see how to become a regulatory affairs specialist.

Most O*NET's occupation experts for this occupation (80%) name a bachelor's degree as the education the job requires.

Job title: Regulatory Affairs Specialist
[Company] · [City, State] · [Full-time or part-time] · [Pay range, where your state requires one]

About the role
[Company] is hiring a Regulatory Affairs Specialist to coordinate and document internal regulatory processes, such as internal audits, inspections, license renewals, or registrations.
[One sentence on your team and why this role matters.]

What you will do
- Coordinate, prepare, or review regulatory submissions for domestic or international projects.
- Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
- Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
- Review adverse drug reactions and file all related reports in accordance with regulatory agency guidelines.
- Coordinate efforts associated with the preparation of regulatory documents or submissions.
- Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.
- 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.

What we are looking for
- [Education: BLS lists a bachelor's degree as typical for this occupation; set the level this role truly needs]
- [Experience: BLS lists no related work experience as typical to enter; set what this role needs]
- Strength in judgment and decision making, reading comprehension and active listening
- Working knowledge of English Language and Law and Government
- [Software your team uses, e.g. Microsoft Excel or Microsoft Office software]
- [Any license or certification your state or company requires]

[Schedule, benefits and how to apply]

Illustrative: every name, employer, school, date and number in these samples is fictional or a bracketed placeholder. Replace each bracket with your own true details; never copy a result you did not achieve.

Not a real job posting. This template is TryHired's illustration built from government occupational data. It is not an opening at any employer, and no employer wrote it.

For the broader BLS occupation Compliance Officers, the median annual wage was $80,730 in May 2025. The broader occupation's median hourly wage was $38.81.

BLS counts the O*NET occupation Regulatory Affairs Specialists within Compliance Officers and publishes no separate wage for it, so the figure is for that broader occupation.

BLS projects employment in the broader occupation Compliance officers to grow 3.8% from 2025 to 2035, with about 32,700 openings a year over that period, including openings to replace workers who leave.

See the full regulatory affairs specialist salary breakdown by percentile, state and metro.

• Read a real regulatory affairs specialist posting next to the core duties above. Duties it repeats, such as “Coordinate, prepare, or review regulatory submissions for domestic or…”, tell you what that employer weighs most; anything it adds is specific to that team.
• Tailor your resume to the posting, not to this page: describe only regulatory affairs specialist work you have actually done, with your own results.
• Prepare a story for each of the top-rated skills (judgment and decision making and reading comprehension).