Regulatory Affairs Associate

Job Description 

  • Compile pre-approval submissions (NDS/ANDS) and post-approval submissions (SNDS, SANDS, NC, PDC-B) for biologics/brand/generic drugs based on internal target dates for filing to Health Canada.
  • Provide technical and strategic support to Global R&D for the filing of complex drug products to achieve high quality submissions to meet the business needs.
  • Communicate effectively with Health Canada and with internal and external clients to support deficiency responses during the drug review process to approval.
  • Coordinate with the manufacturing sites on proposed post-approval changes to ensure compliance for the pharmaceutical and biological products. Review and accurately assess change controls to determine the accurate level of change. 
  • File Annual reports (Level III and YBPRs) and maintain compliance files to keep track of current documents for QA Inspection and product release.
  • Ensure Product Monographs and labeling materials remain current according to Company Core Data Sheets (CCDS) and brand updates.
  • Provide regulatory support to several departments including Operations, Marketing, Quality and Legal to support the launch, release, and continuous supply of product to the market.
  • Provide guidance and support to Regulatory Associates on Regulatory matters.
  • Participate in or direct special projects in the department to improve efficiency.
  • Maintain Product Information Databases.

Job Requirements 

  • B.Sc. in one of the life sciences or biotechnology with a minimum of 2-5 years hands-on experience in brand regulatory submission preparation.
  • Experience in filing biological drug submissions an asset.
    • Sound knowledge of Health Canada regulations and guidelines for pharmaceutical and biological drugs.
  • Familiarity with FDA and ICH guidelines an asset.
  • 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.