Regulatory Affairs Line Manager

Job Summary

Managing regulatory activities for clinical trials, the full-time remote Regulatory Affairs Line Manager will oversee submissions to Ethics Committees and Regulatory Authorities, ensuring compliance with regulations while providing leadership and support to project teams and direct reports.

Key responsibilities

• Coordinate regulatory timelines and deadlines for all assigned projects related to submissions
• Provide regulatory support and advice to project teams, including submission strategies and technical expertise
• Manage and develop direct reports, promoting a positive work environment and achieving organizational goals

Required qualifications

• Bachelor's degree (or equivalent) in a scientific discipline
• 3-5 years of experience in clinical regulatory affairs within the pharmaceutical, biotechnology, or CRO industry
• Working knowledge of regional/national regulatory guidelines and IRB/IEC regulations
• Functional staff management experience is an asset
• Fluency in English, with excellent oral and written communication skills; additional languages are a plus