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

Merck & Co., Inc.

Not specified; not specified; not specified
**
Health canada regulatory submissions
Oncology clinical regulatory expertise
French language proficiency required
** Merck & Co., Inc. is seeking an Associate Director of Regulatory Affairs for Clinical Oncology to oversee oncology projects, manage regulatory submissions, and foster a collaborative team environment. The ideal candidate will have a strong background in regulatory affairs, particularly in oncology, with at least 10 years of experience and a Master's degree in health sciences. **

Job Summary

  • The Associate Director leads regulatory projects within the oncology portfolio, including planning, assignment, and oversight 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 oncology science, company strategy, and the ability to manage critical regulatory submissions like Priority Reviews.

Matching Summary

Match Score: 75

** Merck & Co., Inc. is seeking an Associate Director of Regulatory Affairs for Clinical Oncology to oversee oncology projects, manage regulatory submissions, and foster a collaborative team environment. The ideal candidate will have a strong background in regulatory affairs, particularly in oncology, with at least 10 years of experience and a Master's degree in health sciences. **

Salary

Not specified; Not specified; Not specified

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-functional collaboration skills
  • Continuous process improvement mindset
  • Strategic thinking in oncology
  • Change management capabilities

Key Requirements

  • Minimum 10 years regulatory affairs experience
  • M.Sc. or higher in Health Sciences
  • Completed New Drug Submissions to Health Canada
  • Fluency in French (written and oral)
  • Experience with oncology clinical trials

Work Rights

Not specified

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