Senior Lead, Regulatory CMC

• Develop and implement regulatory CMC strategies for assigned products
• Lead all product-related Regulatory CMC activities across the portfolio and ensure timely execution
• Prepare, review, and maintain CMC documentation for regulatory dossiers
• Develop the corresponding regulatory rationales
• Assess national and international requirements and ensure regulatory compliance
• Contribute to submission strategies
• Support changes to and further development of existing products
• Assess regulatory risks, particularly in connection with variation procedures
• Develop appropriate mitigation measures
• Work closely with internal departments, international partners, and external service providers
• Provide subject-matter guidance to colleagues
• Contribute to cross-functional improvement projects

• Master’s degree in Pharmacy, Chemistry, Biology, or a comparable scientific discipline
• At least 7 years of professional experience in Regulatory CMC within the pharmaceutical industry
• Extensive experience with CMC dossiers, regulatory submissions, and the maintenance of approved medicinal products
• Strong knowledge of national and international regulatory requirements
• Experience providing functional leadership on complex projects and across interfaces
• Matrix or direct people-management experience is an advantage
• Strategic thinking
• Structured and self-directed approach to work
• Excellent communication skills when collaborating with internal departments and external partners
• Excellent German and English language skills

• A responsible role offering significant scope to shape and influence within an international working environment
• Flexible working models with the option to work remotely
• Working-time account with time off in lieu
• 30 days of annual leave
• Individual internal and external training and development opportunities
• Flexibly usable additional benefits budget
• Access to an employee discount platform
• Company and team events