Regulatory Affairs Job at TFS HealthScience, Sweden | Life Sciences | Apply Now
If you are a dual-skilled compliance professional looking to apply both your technical dossier management and good distribution practices to a global pharmaceutical affiliate, this full-time position at TFS HealthScience is an exceptional opportunity. Located in the innovation hub of Stockholm, Sweden, this hybrid role embeds you directly within the Strategic Resourcing Solutions (SRS) Nordics division. For versatile analysts searching for a high-impact Regulatory Affairs Job, this consultant position offers hands-on ownership of national health authority filings, product variations, and local affiliate deviations tracking. It serves as an elite milestone for your career and stands out as a premium Quality Assurance Job for professionals seeking a high-growth Life Sciences Job in the Nordic region.
- Job Position: Quality Assurance / Regulatory Affairs Specialist
- Location:Â Stockholm, Sweden
About The Company
TFS HealthScience is a leading global, mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Founded over 30 years ago in Lund, Sweden, TFS has scaled to bring together over 600 professionals across more than 50 countries, delivering tailored clinical trials across key therapeutic areas such as Dermatology, Neuroscience, Oncology, and Ophthalmology. Through the specialized Functional Service Provider (FSP) framework, TFS deploys dedicated consultant teams directly into top-tier pharmaceutical client environments. This collaborative model ensures a dynamic workspace where you enjoy the operational support of a premier global CRO while making a direct impact on local pharmaceutical market continuity.
Regulatory Affairs Job – Key Responsibilities
As a QA/RA Specialist Consultant, you will split your focus between country-level product registration maintenance and good distribution quality workflows to maintain uninterrupted market supply.
Your core regulatory and quality assurance duties will include:
- Dossier & Submissions Management: Coordinating local variation filings, new regulatory submissions, and full lifecycle maintenance for a designated pharmaceutical product portfolio.
- Labeling Governance: Maintaining fully compliant product labeling, updating summary of product characteristics (SmPC), and managing patient information leaflets (PIL) to ensure adherence to changing guidelines for this Regulatory Affairs Job.
- Health Authority Interface: Acting as a professional point of contact for local regulatory communications and coordinating official information requests from Health Authorities.
- GDP Quality Oversight: Securing strict compliance with Good Distribution Practice (GDP) requirements across the affiliate’s local warehousing and logistics network.
- Defect & Deviations Triage: Processing critical quality deviations, handling technical product complaints, managing recall procedures, and updating internal standard operating procedures (SOPs) to secure a compliant Life Sciences Job.
- Audit & Inspection Readiness: Supporting internal quality management system (QMS) improvements, driving continuous compliance, and preparing files for upcoming regulatory inspections and corporate audits.
Qualifications Required For Regulatory Affairs Job
This consultant track is meticulously tailored for self-motivated, organized analysts who demonstrate strong cross-functional communication habits and can work independently under moving timelines.
- Required Criteria:
- Educational Foundation: A formal university degree in Life Sciences (such as Biology, Biotechnology) or a related scientific discipline.
- Regulatory Track Record: Proven previous experience handling national regulatory submissions, variations, and pharmaceutical product lifecycle management.
- Quality System Exposure: Demonstrated exposure to Quality Assurance workflows, preferably with an active understanding of GDP rules within a wholesale distribution context to advance this Quality Assurance Job.
- Linguistic Mastery: Full professional fluency in English (both written and verbal) is required to coordinate with global study teams and draft technical compliance documentation.
- Preferred Assets:
- Prior experience operating directly within a local pharmaceutical affiliate environment is highly valued.
- Familiarity with electronic common technical document (eCTD) structures and automated quality management software.
In short, the Quality Assurance / Regulatory Affairs Specialist position at TFS HealthScience is a definitive route to transitioning your specialized compliance skills into a diverse, high-visibility consulting portfolio. Securing this role allows you to step away from narrow, siloed administration and actively manage both the health authority dossiers and supply-chain quality protocols that keep life-saving medicines available across Scandinavia. If you live in or can commute to Stockholm, possess a multi-disciplinary compliance background, and want to establish your path with a premier global CRO, apply today to secure this premier Life Sciences Job, launch a highly rewarding Quality Assurance Job, and lock in this outstanding Regulatory Affairs Job.
