Regulatory Affairs Lead – Generics

Role Overview

• Lead and build the Regulatory Affairs team
• Develop and implement regulatory strategies
• Prepare, review and submit regulatory documentation
• Serve as primary contact for national and international regulatory authorities
• Support product development
• Review and ensure regulatory compliance
• Monitor post-marketing regulatory obligations
• Track regulatory changes and standards
• Work closely with cross-functional departments

Requirements

• Degree in a science or pharmaceutical discipline
• At least 5 years of professional experience in Regulatory Affairs within the pharmaceutical industry, preferably in generics
• Experience with EU drug approval procedures
• Strong understanding of global regulatory frameworks, particularly EMA, FDA and ISO
• Excellent written and verbal communication skills
• Analytical mindset with strong problem-solving skills
• Structured, detail-oriented work style and ability to manage multiple projects in parallel
• Proficient with regulatory submission tools and relevant software systems
• Fluent in German and English (business fluent)

Benefits

• An inclusive work environment with development opportunities
• Attractive salary and benefits package
• Highly flexible conditions with a 100% remote option (infrequent travel required)
• Opportunity to work on international, innovative projects with global reach