Regulatory Affairs Associate
Job Description

  • Compile pre-approval (ANDS/ NDS) and post-approval submissions (NC, SANDS, SNDS) that meet the target dates for submissions to Health Canada. Address deficiencies and help manage the response strategy to listed and potential deficiencies. 
  • Communicate effectively with Health Canada and with internal and external clients to support the drug review and approval process.
  • Ensure compliance for a large group of products. Review and accurately assess change controls to determine the appropriate level of change. Maintain Compliance files to keep track of current documents for QA Inspection and product release. Ensure Product Monographs and labeling materials remain up to date.
  • Prepare Annual Reports, Cross-Reference submissions, and Administrative Submissions within target dates.   
  • Liaise with several departments including Global R&D, Operations, Marketing, Quality and Legal to provide regulatory support to achieve high quality submissions that reflect the business needs of all relevant areas of the company.
  • Provide regulatory support for launch activities and provincial formulary listings.
  • Maintain Product Information databases.

Job Requirements

  • B.Sc. in one of the life sciences or chemistry with a minimum of 1-3 years hands-on experience in regulatory submission preparation.
  • Post-Graduate Regulatory Affairs Certificate considered an asset.
  • Strong knowledge of Health Canada regulations and guidelines.
  • Experience with documentation, organizing small projects, working in a deadline environment.
  • Proven ability to learn, correlate diverse data and extrapolate from set examples; documented organizational abilities.
  • Demonstrated time management skills and the ability to prioritize and handle multiple projects is required.
    • Excellent analytical, communication and interpersonal skills.
    • Proficiency with Microsoft Office and Document Management Systems.

Company Overview

Pride in Personnel's experienced and credible consultants are well-versed in the fields of employee search, interviewing and evaluation providing complete consultation throughout the entire process. Our commitment to detail and professionalism provide a superior quality control process ensuring maximum results and efficiency.

Our dedication and expertise in networking and professional recruitment offer an extensive database of superior, qualified candidates.

Pride in Personnel takes great pride in the high level of standards set and adhered to by our consultants. Please take a moment to view our Standards of Excellence.