Regulatory Lead - RWE Study Submission (M/F/D) Tasks : Define regulatory strategy and review study protocol Ensure compliance with RWE / NIS and local ethics requirements Oversee study conduct and documentation Prepare and review CTD sections for submission Manage BfArM interactions and responses Maintain regulatory files and track timelines Qualification: 8 years Regulatory Affairs (Pharma, ideally Ophthalmology) Experience with RWE / NIS and post-approval submissions Strong knowledge of EMA / BfArM guidelines Fluent in English and German Requirements: Start : asap Duration : 6 months Capacity : 1-4 days per week, depending on project phase Location : Remote