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Merck & Co., Inc. is seeking an Associate Director of Regulatory Affairs for Clinical Oncology to oversee oncology projects and collaborate with various stakeholders while ensuring compliance with Health Canada regulations. The ideal candidate should possess a strong background in regulatory affairs, particularly in oncology, and demonstrate effective communication and leadership abilities.
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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 manages critical submissions such as priority reviews.
The position requires a candidate with at least 10 years of experience in clinical regulatory affairs and demonstrated knowledge of the Food and Drug Act.
Matching Summary
Match Score: 75
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Merck & Co., Inc. is seeking an Associate Director of Regulatory Affairs for Clinical Oncology to oversee oncology projects and collaborate with various stakeholders while ensuring compliance with Health Canada regulations. The ideal candidate should possess a strong background in regulatory affairs, particularly in oncology, and demonstrate effective communication and leadership abilities.
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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
Strategic thinking for oncology portfolio
Continuous process improvement mindset
Global regulatory affairs coordination
Key Requirements
Minimum 10 years regulatory affairs experience
M.Sc. or higher in Health Sciences
Completed New Drug Submission filings to Health Canada