The regulatory affairs associate is typically responsible for overseeing regulatory compliance and issues for their firm. This may include representing the regulatory branch of the company at meetings, overseeing technical documentation, and conveying the subject of that documentation to other staff. Preserving quality standards is the most important function of this job; this may include internal and external audits, as well as the development of reports related to performance metrics. The associate should be able to maintain relevant databases, as well as the disseminate promotional materials. The associate also helps maintain the appropriate information on any needed labeling (such as pharmaceutical labeling) for their company's products. This job typically takes place in an office setting during regular business hours, although overtime may be required depending on the needs of the business.
Regulatory Affairs Associate Tasks
Conduct research to support regulatory submissions.
Prepare and submit documentation to regulatory agencies.
Ensure company compliance with all regulations and laws pertaining to company business.
Compile and maintain appropriate technical documents for regulatory submissions.