Regulatory Affairs Specialist
3 weeks ago
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.
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.
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. At least 2 years of experience in Regulatory Affairs in the Pharmaceutical Industry or via a Service Provider
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 products
Experience with change controls on the Canadian market
Fluent English is mandatory, French would be a great plus
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Canada Groupe ProductLife Full timeIn 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. Responsibilities Management of post approval activities (Life Cycle Management) for the Canadian market Initiate change...
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