Regulatory Affairs Specialist in Canada

hace 4 semanas


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

Regulatory Affairs Specialist in Canada

About Us

ProductLife Group is a leading provider of regulatory services for the pharmaceutical industry.

Job Description

We are seeking an experienced Regulatory Affairs Specialist to join our team in Mexico or Canada. As a Regulatory Affairs Specialist, you will be responsible for managing post-approval activities (Life Cycle Management) for the Canadian market.

Key Responsibilities
  • Manage 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 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.
Requirements
  • 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.
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.
Compensation

The estimated salary range for this position is $60,000 - $80,000 per year, depending on experience.



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