Quality Assurance / Regulatory Affairs Specialist

<h2>About this role</h2><p>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 provider solutions.</p><p>We are now looking for a QA/RA Specialist Consultant to join our FSP team in Stockholm.</p><p>In this role, you will work hands-on across both Regulatory Affairs and Quality Assurance, supporting a dedicated project within a global pharmaceutical environment. You will play a key role in ensuring compliance and continuity of operations at the local affiliate.</p><p>This is a great opportunity for someone who enjoys working broadly across QA and RA in a dynamic and collaborative setting.</p><hr><h2>Key Responsibilities</h2><ul><li><p>Manage and support regulatory activities including variations, submissions, and lifecycle maintenance</p></li><li><p>Maintain compliant labeling and support updates for assigned products</p></li><li><p>Interact with local Health Authorities and support regulatory communications</p></li><li><p>Ensure compliance with GDP requirements and support quality processes</p></li><li><p>Handle quality topics such as deviations, complaints, recalls, and documentation</p></li><li><p>Support audits, inspections, and quality system improvements</p></li><li><p>Collaborate cross-functionally with internal and external stakeholders</p></li><li><p>Contribute to maintaining a high standard of compliance across the affiliate</p></li></ul><hr><h2>Qualifications</h2><ul><li><p>Degree in life sciences or a related field</p></li><li><p>Experience within Regulatory Affairs in pharma or biotech</p></li><li><p>Exposure to Quality Assurance, preferably within GDP</p></li><li><p>Understanding of regulatory submissions and product lifecycle management</p></li><li><p>Experience working in an affiliate environment is highly valued</p></li><li><p>Strong communication skills and ability to work independently</p></li><li><p>Fluent in English</p></li></ul><hr><h2>What We Offer</h2><p>We provide opportunities for personal and professional growth in a rewarding environment. You will join a team that values collaboration, quality, and making a real difference for patients.</p><p>Our core values of Trust, Quality, Passion, Flexibility, and Sustainability guide everything we do. By aligning on these values, we create an environment that fosters innovation and long-term success.</p><hr><h2>A Bit More About Us</h2><p>Our journey began over 30 years ago in Sweden, in the city of Lund. As a global CRO, we bring together over 600 professionals across more than 50 countries.</p><p>TFS delivers tailored clinical research services and flexible resourcing solutions across key therapeutic areas including Dermatology, Neuroscience, Oncology, and Ophthalmology.</p>