Project Manager, Regulatory Affairs

@ Merck

Overview

Merck's Regulatory Affairs team brings medical advancements to the world by simplifying communications and procedures. The Project Manager, Regulatory Affairs is responsible for all clinical submission requirements for the assigned product portfolio.

Key Responsibilities and Activities

• Coordinate planning, preparation, and submission of clinical submissions to Health Canada.
• Submit and follow up on clinical trial applications with Health Canada.
• Prepare regulatory submissions and track them until the final regulatory decision.
• Evaluate and communicate Health Canada requests to local and global management.
• Ensure compliance with relevant guidelines, company policies, and SOPs.
• Act as a liaison between global regulatory partners and internal cross-functional teams.

Required Skills and Qualifications

• University degree in health sciences or a related field.
• 2-5 years experience in government standards or related roles within pharma/biotech preferred.
• Functional knowledge of Health Canada requirements for clinical submissions.
• Excellent time management, organizational, and communication skills.
• Proficiency with common office software and ability to learn new systems.
• Fluency in French (if located in Quebec) and English for business communications.

Work Arrangement

This position offers a hybrid work arrangement combining remote work with in-person attendance at the Kirkland Head Office as required.

Key skills/competency

• Clinical Submissions
• Regulatory Affairs
• Health Canada
• Time Management
• Communication
• Compliance
• Collaboration
• Technical Writing
• Project Coordination
• Hybrid Work