Directeur(rice) Associé(e), Affaires Réglementaires - Oncologie Clinique/ Associate Director, Regulatory Affairs - Clinical Oncology

539

Hybrid
10+ years regulatory affairs experience
Health canada new drug submission filings
Oncology clinical portfolio management
The Associate Director of Regulatory Affairs for Clinical Oncology is responsible for overseeing regulatory projects related to oncology products, ensuring successful submissions to Health Canada and fostering collaboration within a virtual team. The role requires extensive experience in regulatory affairs, particularly in oncology, and strong communication and leadership skills

Job Summary

  • The Associate Director leads regulatory projects within the oncology portfolio, including planning and assigning work to specialists.
  • This role serves as the primary contact with Health Canada for the oncology portfolio and manages key regulatory submissions such as Priority Review requests.
  • The position requires a candidate with advanced knowledge of oncology science, company strategy, and the ability to foster a collaborative global regulatory environment.

Matching Summary

Match Score: 85

The Associate Director of Regulatory Affairs for Clinical Oncology is responsible for overseeing regulatory projects related to oncology products, ensuring successful submissions to Health Canada and fostering collaboration within a virtual team. The role requires extensive experience in regulatory affairs, particularly in oncology, and strong communication and leadership skills.

Skills & Requirements

Must-have

  • 10+ years regulatory affairs experience
  • Health Canada New Drug Submission filings
  • Oncology clinical portfolio management
  • French language proficiency required
  • Food and Drug Act interpretation skills

Nice-to-have

  • Virtual team environment leadership
  • Global regulatory collaboration experience
  • Change management initiative leadership
  • Strategic thinking for business needs
  • High-level presentation adaptation skills

Key Requirements

  • Minimum 10 years in clinical regulatory affairs
  • M.Sc. or higher in Health Sciences
  • Completed New Drug Submissions to Health Canada
  • Fluent in French (written and oral)
  • Demonstrated ethics and compliance mindset

Work Rights

Not specified

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