Senior Regulatory Affairs Specialist

📋 Description

• Coordinate regulatory timelines, milestones, and deadlines for regulatory authority (RA) and ethics
• Lead global and multinational submissions for complex, large-scale clinical trials, ensuring
• Respond to sponsor inquiries regarding regulatory requirements, submission procedures, and
• Advise project teams on regulatory strategy, providing local submission guidance and technical
• Prepare and review core and country-specific submission packages, including initial applications
• Conduct peer reviews of regulatory documents and submission packages prepared by colleagues to

🎯 Requirements

• Bachelor's degree or equivalent in a scientific discipline.
• Three to five years of clinical regulatory affairs experience within the pharmaceutical
• Practical experience preparing and submitting Institutional Review Board (IRB) or Independent
• Strong understanding of global regulatory requirements and guidelines applicable to assigned
• Experience coordinating or leading regulatory activities across multiple countries, particularly in
• Experience with the European Union Clinical Trials Regulation (EU-CTR) and its associated

🎁 Benefits

• Permanent, full-time position
• Flexible work schedule to support work-life balance
• Medical, dental, and vision coverage
• Registered Retirement Savings Plan (RRSP) benefits
• Vacation entitlement and personal days
• Access to a virtual medical clinic