Regulatory Affairs Officer - 082

In the context of additional activities for one of our main clients, we are looking for a Regulatory Affairs Officer working from Mexico or Canada to manage post-MAA activities (Life Cycle Management) for the Canadian market.

• Management of post approval activities (Life Cycle Management) for the Canadian market
• Initiate change controls, including regulatory assessment of the change in accordance with Health Canada guidances.
• Coordinate and perform the subsequent regulatory steps until closure of the change control.
• Compile regulatory dossiers in accordance with national requirements.
• Document and track regulatory submissions and regulatory authority approval.
• Provide review of packaging texts.
• Provide format review of Summary of Product Characteristics, Patient Information Leaflets, and labelling (e.g., QRD compliance check).
• Contribute to data entry in PLG tools enabling measurements of KPI, metrics for regulatory services

• Bachelor’s degree or more in a Life Sciences related field. Pharmacy degree would be a plus.
• At least 2 years of experience in Regulatory Affairs in the Pharmaceutical Industry or via a Service Provider