Regulatory Affairs Assistant

Reporting Lines

This person reports into the Senior Regulatory Affairs Officer.

Main Function/Responsibilities of the Job

To help collate documents in preparation for variations and Marketing Authorisation Applications. To prepare regulatory compliance reports.

Primary Tasks

§         To help prepare licence renewals.

§         To advise departments of regulatory information regarding approved shelf life, suppliers etc.

§         To help collate documents for Marketing Authorisation Applications.

§         To prepare Type I variation applications.

§         To help prepare Type II variation applications.

§         To apply for Export Certificates including legalisation and notarisation as necessary.

§         To be available to answer customer queries.

§         Regulatory administration tasks including packaging checks.

Ancillary Tasks 

To be responsible for the cleanliness and tidiness of your individual work station, to ensure a standard of good housekeeping in all areas of the Company.

In addition to the duties and responsibilities listed, the jobholder is required to perform other duties assigned by your Manager from time to time.