Regulatory Affairs Project Manager

Lead pharmaceutical regulatory submissions at Apotex, applying project strategy, risk mitigation, and deficiency response expertise to new product development.As Project Manager, New Product Development, you will lead submission activities within Global Regulatory Affairs. Your work covers due diligence, development submissions, deficiency responses, change controls, and launch support. You will collaborate with internal colleagues and development partners.Key Responsibilities:
Develop regulatory project strategies with appropriate risk mitigationPrepare and lead submissions under current requirementsAssess potential deficiencies before submissionLead deficiency response strategies with stakeholdersConduct regulatory due diligence for new opportunitiesRequirements:
Bachelor of Science in a related required fieldEight or more years of pharmaceutical regulatory affairs experienceStrong knowledge of new drug submission requirementsKnowledge of Canadian and United States regulatory guidelinesExcellent communication, leadership, and organisational skillsBring regulatory strategy, submission leadership, and pharmaceutical development expertise to Apotex’s new product portfolio.
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