Regulatory Compliance Specialist

hace 2 meses

Ciudad de México, Ciudad de México ProductLife Group A tiempo completo

Regulatory Affairs Officer - 082

We are seeking a dedicated Regulatory Affairs Officer to oversee post-marketing authorization activities (Life Cycle Management) specifically for the Canadian market. This role is essential in ensuring compliance with regulatory standards and maintaining product integrity.

Key Responsibilities:

  • Oversee post-approval processes (Life Cycle Management) for the Canadian market.
  • Initiate and manage change controls, ensuring regulatory evaluations align with Health Canada guidelines.
  • Coordinate and execute the necessary regulatory procedures until the change control is finalized.
  • Compile and prepare regulatory submissions in accordance with national regulations.
  • Maintain accurate documentation and track submissions and approvals from regulatory authorities.
  • Review and provide feedback on packaging texts.
  • Ensure compliance of Summary of Product Characteristics, Patient Information Leaflets, and labeling through format reviews (e.g., QRD compliance checks).
  • Contribute to data entry in PLG tools to facilitate the measurement of KPIs and metrics for regulatory services.

Education & Experience:

  • A Bachelor's degree or higher in a Life Sciences discipline; a Pharmacy degree is advantageous.
  • A minimum of 2 years of experience in Regulatory Affairs within the Pharmaceutical sector or through a Service Provider.

Skills:

Technical Skills:

  • Proven experience in managing regulatory lifecycle activities for drug products (Renewals, Change Controls, PI updates, technical variations) in Canada.
  • Comprehensive knowledge of Canadian regulations pertaining to pharmaceuticals (NCE, Biologicals, and Biotech), Medical Devices, and Combination products.
  • Familiarity with CMC documentation (Module 3) relevant to the Canadian market.
  • Experience handling change controls specific to the Canadian regulatory environment.

Soft Skills:

  • Proficiency in English is essential; knowledge of French is a significant advantage.
  • Strong organizational and interpersonal skills.
  • Excellent communication abilities.
  • Capability to work effectively both independently and as part of a team.
  • Competence in prioritizing multiple tasks and managing workloads efficiently.
  • Ability to meet tight deadlines while maintaining quality.
  • Detail-oriented with a process-driven mindset.
  • A proactive approach to problem-solving.

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