Quality Assurance / Regulatory Affairs Specialist

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 provider solutions.

We are now looking for a QA/RA Specialist Consultant to join our FSP team in Stockholm.

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.

This is a great opportunity for someone who enjoys working broadly across QA and RA in a dynamic and collaborative setting.

Key Responsibilities

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Manage and support regulatory activities including variations, submissions, and lifecycle maintenance

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Maintain compliant labeling and support updates for assigned products

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Interact with local Health Authorities and support regulatory communications

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Ensure compliance with GDP requirements and support quality processes

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Handle quality topics such as deviations, complaints, recalls, and documentation

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Support audits, inspections, and quality system improvements

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Collaborate cross-functionally with internal and external stakeholders

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Contribute to maintaining a high standard of compliance across the affiliate

Qualifications

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Degree in life sciences or a related field

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Experience within Regulatory Affairs in pharma or biotech

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Exposure to Quality Assurance, preferably within GDP

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Understanding of regulatory submissions and product lifecycle management

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Experience working in an affiliate environment is highly valued

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Strong communication skills and ability to work independently

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Fluent in English

What We Offer

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.

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.

A Bit More About Us

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.

TFS delivers tailored clinical research services and flexible resourcing solutions across key therapeutic areas including Dermatology, Neuroscience, Oncology, and Ophthalmology.