Regulatory Affairs Specialist

hace 1 día


Ciudad de México, Ciudad de México ProductLife Group A tiempo completo
Regulatory Affairs Officer

ProductLife Group is seeking a highly skilled Regulatory Affairs Officer to manage post-MAA activities for the Canadian market.

Responsibilities
  • Manage post-approval activities (Life Cycle Management) for the Canadian market, ensuring compliance with Health Canada guidelines.
  • Initiate change controls, including regulatory assessments and coordinate subsequent regulatory steps until closure.
  • Compile regulatory dossiers in accordance with national requirements and document regulatory submissions and approvals.
  • Provide review of packaging texts, format reviews of Summary of Product Characteristics, Patient Information Leaflets, and labeling, ensuring QRD compliance.
  • Contribute to data entry in PLG tools, enabling measurements of KPIs and metrics for regulatory services.
Requirements
  • Bachelor's degree or more in a Life Sciences related field, with a Pharmacy degree being a plus.
  • At least 2 years of experience in Regulatory Affairs in the Pharmaceutical Industry or via a Service Provider.
Skills
  • Experience in regulatory lifecycle maintenance activities for drug products in Canada, including renewals, change controls, and PI updates.
  • Knowledge of Canadian regulations for pharmaceuticals, medical devices, and combination products.
  • Fluent English is mandatory, with French being a great plus.
  • Excellent organizational, interpersonal, and communication skills, with the ability to work well within a team and autonomously.


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