Take the lead in Regulatory Affairs at a prominent biopharmaceutical company in Canada. Drive the regulatory strategy for oncology and collaborate globally to ensure compliance and successful outcomes.Reporting to the Vice-President & General Manager, you will provide hands-on leadership and strategic direction in regulatory affairs. This role involves overseeing the full product lifecycle, managing submissions, and interacting with Health Canada.
Your expertise will be crucial for maintaining alignment between Canadian and global regulatory frameworks.Key Responsibilities:Lead development of Canadian regulatory strategies for oncology programsEnsure compliance of regulatory submissions with Canadian standardsServe as primary contact with Health Canada for approvalsOversee Scientific Advice Briefing Packages and regulatory applicationsProvide input into clinical trial design and labelling strategiesRequirements:12+ years in Regulatory Affairs within pharma or biotechStrong experience in oncology drug developmentDeep understanding of Canadian regulatory frameworksProven success in Health Canada submissionsExcellent communication and relationship management skillsLead creative regulatory strategies and engage with cross-functional teams to drive market success.#J-18808-Ljbffr
📌 Head Of Regulatory Affairs In Canada (Toronto)
🏢 MedAccess Recruiters
📍 Toronto
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