Senior Manager Regulatory Affairs

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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