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

Merck & Co., Inc.

**
Health canada regulatory submissions
Oncology clinical portfolio management
French language fluency required
** Merck & Co., Inc. is seeking an Associate Director of Regulatory Affairs specializing in Clinical Oncology, responsible for overseeing oncology projects, engaging with Health Canada, and ensuring compliance with regulatory requirements. The ideal candidate should have at least 10 years of experience in regulatory affairs, particularly in oncology, along with strong communication and collaboration skills. **

Job Summary

  • The Associate Director is responsible for leading regulatory projects within the oncology portfolio, including planning and assigning tasks to specialists.
  • This role serves as the primary contact with Health Canada for the oncology portfolio and represents the company in global regulatory meetings.
  • The position requires a deep understanding of the Food and Drug Act and the ability to interpret complex regulatory guidance documents impacting clinical submissions.

Matching Summary

Match Score: 75

** Merck & Co., Inc. is seeking an Associate Director of Regulatory Affairs specializing in Clinical Oncology, responsible for overseeing oncology projects, engaging with Health Canada, and ensuring compliance with regulatory requirements. The ideal candidate should have at least 10 years of experience in regulatory affairs, particularly in oncology, along with strong communication and collaboration skills. **

Skills & Requirements

Must-have

  • Health Canada regulatory submissions
  • Oncology clinical portfolio management
  • French language fluency required
  • Food and Drug Act interpretation
  • Priority review submission experience

Nice-to-have

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

Key Requirements

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

Work Rights

Not specified

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