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.
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Regulatory Affairs Project Manager in Toronto employer: APOTEX
At Apotex, we pride ourselves on being an exceptional employer that fosters a dynamic and inclusive work culture. As the Director of Retail Sales Strategy, you will not only lead a talented team but also have access to extensive professional development opportunities and innovative resources to drive your career forward. Located in a vibrant community, our commitment to employee well-being and growth ensures that you can make a meaningful impact while enjoying a rewarding work-life balance.
