Chef de projets, Affaires réglementaires / Proj...

@ MSD

Overview

The Chef de projets, Affaires réglementaires / Project Manager, Regulatory Affairs at MSD is responsible for all clinical submission requirements for a designated product portfolio. This role serves as the primary resource for government standards and works closely with local and global regulatory teams, chemical manufacturing control units, and external agencies like Health Canada.

Key Responsibilities

• Coordinate planning, preparation, and submission of clinical submissions (e.g., NDS, SNDS, PSUR, RMP) to Health Canada.
• Submit and follow up on clinical trial applications and regulatory submissions.
• Serve as the primary liaison with Health Canada, addressing information requests and regulatory queries.
• Ensure compliance with the Food and Drugs Act, relevant guidelines, company policies, and SOPs.
• Collaborate with internal cross-functional teams and global regulatory partners.

Qualifications and Skills

A University degree (B.Sc. or higher in health sciences or related field) is required, with preferred experience of two to five years in regulatory affairs within the pharmaceutical or biotechnology industries. Strong time management, communication, collaborative skills, and proficiency with office software are essential. French language skills are required if located in Quebec, with English necessary for global communication.

Work Arrangement

This position follows a hybrid work arrangement, combining remote work and in-person presence at the Kirkland Head Office.

Key skills/competency

• Regulatory Submissions
• Health Canada
• Clinical Submissions
• Project Management
• Regulatory Compliance
• Chemical Manufacturing Control
• Communication
• Collaboration
• Health Sciences
• Hybrid Work