Regulatory Affairs Manager

For our client, a leading pharmaceutical company based in Switzerland, we are looking for a

Regulatory Affairs Manager 100% (Ref. Nr. 3003)
Biologics portfolio – permanent position

Your main tasks

• Develop and execute regulatory strategies for biologics products across EU and Swiss markets.

• Prepare and submit Marketing Authorization Applications (MAAs) and variation submissions.

• Interact with Swissmedic, EMA, and national competent authorities during review processes.

• Provide regulatory guidance to cross-functional teams including R&D, CMC, and Commercial.

• Monitor evolving regulatory guidelines and assess impact on the product portfolio.

Your profile

• Master's degree or PhD in Pharmacy, Chemistry, Biology, or related discipline.

• 5-8 years of regulatory affairs experience with biologics or biosimilars.

• Proven track record of successful MAA submissions in Switzerland and/or EU.

• Excellent knowledge of CTD format and eCTD publishing.

• Strong communication skills in English; French or German advantageous.