Regulatory Affairs Manager 100 %

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