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    Regulatory Affairs Officer - Mexico City, México - ProductLife Group

    ProductLife Group
    ProductLife Group Mexico City, México

    hace 5 días

    Default job background
    Permanent contract
    Descripción

    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.

    Group 10 Responsibilities
  • 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
    • Group 11 Education & Experience
  • 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
    • Group 13 Skills

    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
  • Knowledge of CMC documents (Module 3) on the Canadian market
  • Experience with change controls on the Canadian market

    • Soft skills:

  • Fluent English is mandatory, French would be a great plus
  • Excellent organizational and interpersonal skills
  • Excellent communication skills
  • Ability to work well within a team and autonomously
  • Ability to prioritize different workloads/multi-task
  • Ability to deliver on tight timelines
  • Process orientated with good attention to detail
  • Solution driven
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