job title: Regulatory operations associate(icon)

Key responsibilities

• Provide support for submissions and other documents by performing necessary tasks including photocopying, scanning and printing, assembly, dispatch and coordinating resources for submissions

• Responsible for all aspects of publishing submissions and/or submission components for internal review and signoff, and for submission to regulatory authorities.

• Preparation of published output for either paper or electronic formats ensuring high-quality documents in adherence with regulatory guidelines and internal processes within established time lines

• Assemble electronic and paper Regulatory Submissions and packages for Health Canada, US Food and Drug Administration, the European Medicines Agency and other international regulatory authorities using specialty EDMS/publishing software

• Perform quality review of Regulatory Operations team members work to ensure accuracy

• Responsible for managing project workflow throughout the submission process, including prioritizing project objectives, and overseeing progress of projects with other team members, ensuring timeframes and deadlines are met and identifying and relaying issues and resource needs when required

What you will need:

• B.Sc. or related degree in Health Sciences or Information Technology / Computer Sciences or equivalent relevant experience and training. RAC certification an asset

• 2 years pharmaceutical regulatory industry / regulatory operations experience

• Experience working with current eCTD standards desirable

• Understanding of applicable regulations and guidelines documents