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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
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