Regulatory Affairs Associate Canada
GlaxoSmithKline plc
Support Canadian regulatory submissions at GSK as a Regulatory Affairs Associate, using scientific judgment and collaboration in a hybrid Mississauga role.This 12-month contract supports regulatory activities across GSK’s portfolio of vaccines, specialty medicines, and general medicines. You will contribute to submission planning, Health Canada communications, compliance, and project issue resolution. The position suits a scientific professional with some regulatory affairs experience.Key Responsibilities:
Provide input into submission and activity planningAssist with NDS, SNDS, CTA, and NC preparationEnsure compliance with Health Canada, industry, and GSK guidelinesPrepare internal reports and Health Canada responsesCommunicate project plans and issues with global and local teamsRequirements:
Bachelor of Science in life science or relevant scientific fieldSome experience in regulatory affairsUnderstanding of Canadian Food and Drug RegulationsKnowledge of submission requirements and processesExperience working with Veeva VaultBring regulatory knowledge, attention to detail, and collaborative communication to GSK’s Canadian regulatory affairs activities.
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Provide input into submission and activity planningAssist with NDS, SNDS, CTA, and NC preparationEnsure compliance with Health Canada, industry, and GSK guidelinesPrepare internal reports and Health Canada responsesCommunicate project plans and issues with global and local teamsRequirements:
Bachelor of Science in life science or relevant scientific fieldSome experience in regulatory affairsUnderstanding of Canadian Food and Drug RegulationsKnowledge of submission requirements and processesExperience working with Veeva VaultBring regulatory knowledge, attention to detail, and collaborative communication to GSK’s Canadian regulatory affairs activities.
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Vacancy posted 56 minutes ago
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