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vor 20 Stunden

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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

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