In this role, you will oversee the preparation and management of regulatory submissions for medicinal products in Switzerland. You will ensure compliance with Swissmedic requirements and collaborate with cross-functional teams to maintain and update marketing authorization dossiers. The position demands a strategic approach to regulatory processes and thorough knowledge of local guidelines.

Start Date: 01/08/2025

Duration: Permanent

Key Responsibilities

Prepare and compile initial marketing authorization applications (MAAs) in accordance with Swissmedic standards
Manage lifecycle activities for existing marketing authorizations, including variations, renewals, and updates, ensuring compliance with Swiss and international regulations
Draft, review, and update clinical and non-clinical summaries, overviews, and modules for the Swiss eCTD
Coordinate with medical, quality, and pharmacovigilance teams to collect, validate, and align data for submissions
Provide strategic guidance on regulatory affairs and ensure alignment with overall regulatory strategies
Oversee regulatory information systems and internal tracking tools to ensure data accuracy and timely updates
Keep abreast of current regulatory guidelines and procedures relevant to Swissmedic

Job ID: 41180890

Candidate Profile

Master’s degree in Life Sciences, Pharmacy, or a related field
At least 5 years of practical experience in regulatory affairs, specifically with Swiss marketing authorizations
In-depth knowledge of Swissmedic regulations, eCTD dossier requirements, and ICH guidelines
Experience in preparing clinical and non-clinical overviews and summaries
Ability to handle multiple projects, prioritize tasks, and work independently with minimal supervision
Excellent communication skills with a collaborative, proactive approach
Languages: English (C1), French (C1), German (C1)

Nice to Have

Familiarity with EU regulatory procedures
Experience with global registration processes in markets such as the UK, Singapore, Australia, or Canada