Regulatory Affairs Manager – Generics

Role Overview

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

Requirements

• University degree (e.g., pharmaceutical or life sciences)
• Professional experience in Regulatory Affairs
• Excellent German and English language skills
• Analytical thinking, quick comprehension, and strong organizational skills
• Team player with strong communication skills

Benefits

• Flexible working conditions (including remote work/home office)
• 30 days annual leave + 3 bridge days
• A friendly team
• Attractive salary & comprehensive social benefits (including pension and health insurance)
• Excellent training and development opportunities