The Laboratory Animal Management Association is seeking an Associate Director of Regulatory Affairs specializing in Clinical Oncology. This hybrid role involves overseeing regulatory projects, engaging with clinical specialists, and acting as the primary point of contact with Health Canada for oncology products
Job Summary
The Associate Director will lead and supervise clinical specialists to manage a portfolio of oncology products while fostering a virtual team environment.
This role serves as the primary contact for Health Canada regarding oncology submissions, including priority reviews and product safety issues.
The position requires advanced knowledge of the Food and Drug Act and the ability to interpret complex regulatory guidance documents impacting clinical compliance.
Matching Summary
Match Score: 85
The Laboratory Animal Management Association is seeking an Associate Director of Regulatory Affairs specializing in Clinical Oncology. This hybrid role involves overseeing regulatory projects, engaging with clinical specialists, and acting as the primary point of contact with Health Canada for oncology products.
Skills & Requirements
Must-have
Health Canada regulatory submissions
Oncology portfolio management
French language proficiency required
10 years regulatory affairs experience
New Drug Submission filings
Nice-to-have
Virtual team environment leadership
Cross-cultural collaboration skills
Strategic thinking in oncology
Change management initiatives
Continuous process improvement focus
Key Requirements
M.Sc. or higher in Health Sciences
Minimum 10 years in clinical regulatory affairs
Experience with New Drug Submissions to Health Canada