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
Place of Work: Neuchatel
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
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