Regulatory Affairs Specialist

Regulatory Affairs Specialist

TFS HealthScience

Gothenburg, Sweden

The Regulatory Affairs Specialist is responsible for preparing, managing and completing regulatory activities to support clinical trials while ensuring compliance with all applicable guidelines and regulatory requirements.

Key Responsibilities

• Prepare, review and compile regulatory submissions for clinical trial applications and supporting documentation
• Liaise with health authorities and provide regulatory insight and responses to regulatory questions
• Maintain regulatory files, trackers and documentation to ensure full compliance
• Support regulatory strategy for assigned studies and provide guidance to internal stakeholders
• Participate in study meetings, communicate regulatory updates and ensure alignment with requirements
• Contribute to continuous improvement initiatives, SOP updates and regulatory intelligence activities

Qualifications

• Bachelor’s degree in life science, pharmacy or equivalent
• Minimum 5 years of regulatory affairs experience in clinical research
• Strong understanding of GCP, ICH guidelines and EU Clinical Trial Regulation
• Ability to work independently and prioritize effectively in a dynamic environment
• Excellent verbal and written communication skills
• Proficiency in Word, Excel, MS Project and regulatory documentation tools