Compliance

• Independent management of procedures in pharmaceutical drug approvals
• Preparation of regulatory submission documentation in eCTD format and submission to authorities
• Life-cycle management (renewals, variations)
• Direct contact with regulatory authorities and point of contact for internal and external RA inquiries
• Maintenance and optimization of the regulatory information database
• Drafting and reviewing product information texts

Regulatory Affairs Manager – Generics

Regulatory Affairs Manager – Generika

Senior Consultant Risk & Regulatory

Consultant Risk & Regulatory