Regulatory Affairs Specialist

4 days ago

Gothenburg, Västra Götaland, Sweden TFS HealthScience Full time 750,000 - 1,050,000 per year


About this role

TFS HealthScience is a leading global mid size Contract Research Organization that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service capabilities, resourcing and Functional Service solutions.

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. This is a one year contract position at 0.4 FTE within a dedicated study team.

As part of our SRS FSP team, you will be dedicated to one sponsor, contributing to regulatory activities supporting international clinical research programs.

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

What We Offer

We provide a competitive compensation package, comprehensive benefits and opportunities for personal and professional growth in a rewarding environment. You will join a team that values collaboration, innovation and making a difference in the lives of patients.

A Bit More About Us

Our journey began over 27 years ago in Sweden, in the city of Lund. As a full service global Contract Research Organization, we build solution driven teams working toward a healthier future. Bringing together over 800 professionals, TFS delivers tailored clinical research services in more than 40 countries with flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology, Neuroscience, Oncology and Ophthalmology.

Our core values of Trust, Quality, Passion, Flexibility and Sustainability guide decision making across the organization. They help us attract and retain talented professionals who share these principles, creating a unified culture focused on innovation, respect and collaboration. Together we make a difference.

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