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 mitigation
Prepare and lead submissions under current requirements
Assess potential deficiencies before submission
Lead deficiency response strategies with stakeholders
Conduct regulatory due diligence for new opportunities
Requirements:

Bachelor of Science in a related required field
Eight or more years of pharmaceutical regulatory affairs experience
Strong knowledge of new drug submission requirements
Knowledge of Canadian and United States regulatory guidelines
Excellent communication, leadership, and organisational skills
Bring regulatory strategy, submission leadership, and pharmaceutical development expertise to Apotex’s new product portfolio.

#J-18808-Ljbffr