The position of Associate Director of Regulatory Affairs in Clinical Oncology involves overseeing regulatory projects and submissions related to oncology products, while fostering a collaborative team environment. The role requires a strong background in regulatory affairs, particularly within oncology, as well as significant experience with Health Canada submissions
Job Summary
The Associate Director will lead and supervise regulatory projects within the oncology portfolio, including planning and assignment of key initiatives.
This role serves as the primary contact for Health Canada regarding the oncology portfolio and represents the company in global regulatory meetings.
The position requires a candidate with advanced knowledge of product science, company strategy, and the ability to intervene on critical regulatory submissions such as Priority Review requests.
Matching Summary
Match Score: 85
The position of Associate Director of Regulatory Affairs in Clinical Oncology involves overseeing regulatory projects and submissions related to oncology products, while fostering a collaborative team environment. The role requires a strong background in regulatory affairs, particularly within oncology, as well as significant experience with Health Canada submissions.
Skills & Requirements
Must-have
10 years regulatory affairs experience
Health Canada submission expertise
Oncology clinical portfolio management
French language fluency required
Food and Drug Act knowledge
Stakeholder management with Health Canada
Nice-to-have
Virtual team environment leadership
Continuous process improvement mindset
Cross-cultural collaboration skills
Strategic thinking for oncology business
Adaptability to changing regulations
Key Requirements
Minimum 10 years experience in clinical regulatory affairs
Advanced University Degree (M.Sc. or higher) in Health Sciences
Completed New Drug Submission filings to Health Canada
Fluency in French (written and oral)
Demonstrated knowledge of Food and Drug Act and Regulations