Regulatory Affairs Specialist in Canada
hace 4 semanas
Regulatory Affairs Specialist in Canada
About UsProductLife Group is a leading provider of regulatory services for the pharmaceutical industry.
Job DescriptionWe 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.
- 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.
- 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.
- 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.
The estimated salary range for this position is $60,000 - $80,000 per year, depending on experience.
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