Regulatory Affairs Manager

Regulatory Affairs Manager

TFS HealthScience

Remote, Sweden

The Regulatory Affairs Manager (Freelance, 0.5 FTE) is responsible for hands on preparation, coordination and execution of global regulatory activities for clinical trials. This role supports regulatory submissions, authority interactions and regulatory strategy within assigned study teams.

As part of our SRS/FSP team, you will be dedicated to one sponsor, a global pharmaceutical or biotech company that is an industry leader in international clinical development.

Key Responsibilities

• Prepare, review and compile global regulatory submissions for clinical trials;
• Coordinate and manage regulatory authority interactions and responses;
• Submit and support clinical trial applications in the EU and other regions;
• Develop regulatory documentation for submissions and scientific advice meetings;
• Maintain regulatory trackers and electronic files in compliance with SOPs;
• Provide regulatory guidance and strategic input to sponsor teams.

Qualifications

• Bachelor’s degree in life science, pharmacy or equivalent;
• Minimum 5 years of relevant regulatory affairs experience;
• Strong understanding of GCP, ICH guidelines and Clinical Trial Regulation;
• Ability to work independently in a fast paced environment with shifting priorities;
• Excellent communication skills and proficiency with standard software tools.