Adecco
Regulatory & Quality Affairs Specialist (m/f/d) Location: Central Switzerland / Remote | Workload: [80?100%]
In this key position, you will manage the preparation, submission, and maintenance of marketing authorisation dossiers for medicinal products in Switzerland. Acting as the main contact for Swissmedic, suppliers, and strategic partners, you ensure full regulatory compliance. As Qualified Person / Responsable Technique, you will take responsibility for GDP-compliant processes, batch release, and quality management.
Responsibilities
Prepare and maintain regulatory dossiers (MAAs, variations, renewals)
Coordinate with internal departments and external partners
Act as Qualified Person / Responsable Technique under Swiss law
Ensure GDP/GMP compliance and oversee the QMS
Approve batch releases and support audits/inspections
Maintain SOPs, quality agreements, and regulatory databases
Monitor regulatory changes and update processes accordingly
Lead preparation and follow-up for Swissmedic inspections
Support CAPA management, deviation handling, and change control processes
Profile
Degree in Life Sciences/Pharmacy or equivalent
Several years' experience in Regulatory Affairs and Quality Assurance (GDP/GMP)
Strong knowledge of Swissmedic requirements and eCTD submissions
Experience as Qualified Person / Responsable Technique
Strong project management and cross-functional collaboration skills
Excellent written and verbal communication in English (German an asset)
Independent, structured working style with high attention to detail
Nice to have
Experience with EU or global regulatory submissions
Knowledge of Pharmacovigilance / Drug Safety
Familiarity with international GDP/GMP standards
Benefits
A dynamic and collaborative work environment within the life sciences industry
Exciting projects with a high level of autonomy and responsibility
Opportunities for continuous learning and professional development
Competitive compensation and benefits package
Flexible working arrangements to support work-life balance
The chance to make a meaningful impact on the quality and safety of medicinal products in Switzerland
Contact information
In case of any questions related to this vacancy (ref.: JN -082025-831719), please contact Marcel Nürnberg at +41 58 233 44 80.
About Us
Adecco is the market leader for staffing solutions in Switzerland and worldwide. Every day, our teams in our 50 locations throughout Switzerland ensure the best match between candidates and clients in various professional fields and industries. Adecco Switzerland is part of the Adecco Group, the world's leading talent advisory and solutions company. We believe in making the future work for everyone, and every day enable more than 3.5 million careers. We skill, develop, and hire talent in 60 countries, enabling organisations to embrace the future of work.
TEMP
Life Sciences
Branche: Anderes
Funktion: Anderes
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