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.
ResponsibilitiesManagement of post approval activities (Life Cycle Management) for the Canadian marketInitiate 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 servicesEducation & ExperienceBachelor'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 ProviderSkills Hard/Technical skills:
Experience in regulatory lifecycle maintenance activities for drug products (Renewals, Change Controls, PI updates, technical variations) in Canada (to Health Canada)Knowledge of the Canadian (CA) regulations for pharmaceuticals (NCE, Biologicals and Biotech), Medical Devices, Combination productsKnowledge of CMC documents (Module 3) on the Canadian marketExperience with change controls on the Canadian marketFluent English is mandatory, French would be a great plusExcellent organizational and interpersonal skillsAbility to work well within a team and autonomouslyAbility to prioritize different workloads/multi-taskAbility to deliver on tight timelinesProcess orientated with good attention to detail#J-18808-Ljbffr