Career Details for Regulatory Affairs Specialists
Drug Regulatory Affairs Specialist, Regulatory Affairs Associate, Regulatory Affairs Specialist, Regulatory Submissions Associate
What they do:
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.
On the job, you would:
- Coordinate, prepare, or review regulatory submissions for domestic or international projects.
- Provide technical review of data or reports that will 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.
Arts and Humanities
- English language
Safety and Government
- law and government
- administrative services
- reading work related information
- thinking about the pros and cons of different ways to solve a problem
- noticing a problem and figuring out the best way to solve it
People and Technology Systems
- figuring out how a system should work and how changes in the future will affect it
- thinking about the pros and cons of different options and picking the best one
- read and understand what is written
- communicate by writing
Ideas and Logic
- notice when problems happen
- make general rules or come up with answers from lots of detailed information
People interested in this work like activities that include data, detail, and regular routines.
- Attention to Detail
- Analytical Thinking
- Stress Tolerance
You might use software like this on the job:
Data base user interface and query software
- FileMaker Pro
- Microsoft Access
- Healthcare common procedure coding system HCPCS
- Medical procedure coding software
Document management software
- Adobe Systems Adobe Acrobat
- Atrion Intelligent Authoring
|New job opportunities are likely in the future.|
|per year, on average|
|This career is part of the green economy.|