Regulatory Affairs Specialists
Also known as: Anti Money Laundering Compliance Analyst (AML Compliance Analyst), Clinical Quality Assurance Associate, Clinical Quality Assurance Specialist (+22 more)
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.
Take our free 15-minute assessment to see how well this career fits YOUR unique profile
What You'll 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.
Essential Skills
Career Fit Overview
Use this summary to sense whether the day to day rhythm and focus of this path line up with what energizes you.
Top passions
- Organizer: Bringing order to data and processes satisfies you.
- Leader: Taking charge and moving ideas forward motivates you.
- Analyst: Investigating problems and finding patterns keeps you engaged.
Common styles
Attention to Detail, Integrity, Dependability, Cooperation, Analytical Thinking
Want a personal read on fit. Take the free assessment and see your exact compatibility with this career and many related roles.
Key Abilities
This career demands strong capabilities in the following areas:
Technologies & Tools
Work Environment & Style
Common Styles for This Career
- Attention to Detail (High importance: 4.75/5)
- Integrity (High importance: 4.6/5)
- Dependability (High importance: 4.35/5)
- Cooperation (High importance: 4.2/5)
- Analytical Thinking (High importance: 4.0/5)
Want to see how YOUR work style matches this career?
Take Free 15-Min Assessment →How to Become One
Most employers require a bachelor's degree in a relevant field. Some positions may also require experience through internships, co-ops, or entry-level work to strengthen your candidacy.
Similar Careers to Explore
Insurance Underwriters
99.9% similar profile
Claims Adjusters, Examiners, and Investigators
99.8% similar profile
Credit Analysts
99.7% similar profile
Financial Examiners
99.7% similar profile
Budget Analysts
99.6% similar profile
Legal Secretaries and Administrative Assistants
99.6% similar profile
Compensation, Benefits, and Job Analysis Specialists
99.3% similar profile
Accountants and Auditors
99.3% similar profile
Also Known As
This career is known by many different job titles across industries. Here are all the variations:
Ready to Discover Your Perfect Career?
Our scientific assessment measures your styles, passions, and drivers to match you with careers where you'll thrive.
Take Free Assessment (15 min) →