Regulatory Affairs Manager

Responsibilities

• 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.

Requirements

• 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.

Nice to have

• French or German advantageous.