Role Overview
This position involves overseeing regulatory submissions for medicinal products in Switzerland.
* Ensure compliance with Swissmedic requirements and regulations.
* Collaborate with cross-functional teams to maintain and update marketing authorization dossiers.
Key Responsibilities
* Prepare and compile initial marketing authorization applications (MAAs) according to Swissmedic standards.
* Manage lifecycle activities for existing marketing authorizations, including variations, renewals, and updates.
* 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.
* Stay up-to-date with current regulatory guidelines and procedures relevant to Swissmedic.
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, French, German.