Compliance

• Independently manage procedures for medicinal product approvals
• Prepare regulatory submission documentation in eCTD format and submit it to the authorities
• Life-cycle management (renewals, variations)
• Direct contact with regulatory authorities and serve as a point of contact for internal and external Regulatory Affairs queries
• Maintain and optimize the regulatory information database
• Draft and review product information texts

Regulatory Affairs Manager – Generics

Consultant Risk & Regulatory, Project locations Munich, Hamburg, Berlin, Frankfurt

Compliance Analyst

Consultant Risk & Regulatory

Compliance Manager