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

Merck & Co., Inc.

Hybrid
Health canada regulatory submissions
Oncology clinical regulatory expertise
French language proficiency required
Merck & Co., Inc. is seeking an Associate Director for Regulatory Affairs in Clinical Oncology, responsible for overseeing oncology projects and regulatory submissions while fostering a collaborative team environment. The ideal candidate will have extensive experience in regulatory affairs, particularly in oncology, and must possess advanced communication skills in both French and English

Job Summary

  • The Associate Director leads regulatory projects within the oncology portfolio, including planning, assignment, and oversight of key submissions to Health Canada.
  • This role serves as the primary contact for Health Canada, local stakeholders, and global regulatory affairs teams regarding oncology programs and safety issues.
  • The position requires a candidate with at least 10 years of experience in clinical regulatory affairs, preferably with specific expertise in oncology and New Drug Submissions.

Matching Summary

Match Score: 85

Merck & Co., Inc. is seeking an Associate Director for Regulatory Affairs in Clinical Oncology, responsible for overseeing oncology projects and regulatory submissions while fostering a collaborative team environment. The ideal candidate will have extensive experience in regulatory affairs, particularly in oncology, and must possess advanced communication skills in both French and English.

Skills & Requirements

Must-have

  • Health Canada regulatory submissions
  • Oncology clinical regulatory expertise
  • French language proficiency required
  • New product registration management
  • Priority review submission experience

Nice-to-have

  • Virtual team environment leadership
  • Cross-cultural collaboration skills
  • Strategic thinking in oncology
  • Change management initiatives
  • Continuous process improvement focus

Key Requirements

  • Minimum 10 years regulatory affairs experience
  • M.Sc. or higher in Health Sciences
  • Completed New Drug Submission filings to Health Canada
  • Fluency in French (written and oral)
  • Advanced knowledge of Food and Drug Act

Work Rights

Not specified

Tailored Resume

Cover Letter