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.
A bachelor's degree in a relevant technical field is generally required for this position, as is relevant experience. Regulatory affairs associates also must have knowledge of standards, regulations, and protocols relevant to the company's field. The associate must have exceptional communication skills, be detail-oriented, and have excellent multitasking skills. Additionally, they need to be proficient in electronic document management systems, publishing systems, and various technical software programs related to the mission and technical focus of the company. It is also important that they are proficient in standard office software.
Regulatory Affairs Associate Tasks
Support company in regulatory matters.
Evaluate compliance with regulatory policy and procedures.
Prepare, review, and file regulatory documents.
Research and make recommendations on regulatory policy.