Regulatory & Quality Affairs Specialist (m/f/d)

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.