Senior Lead Regulatory CMC

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

• Completed 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 lifecycle management of authorized medicinal products
• Proficiency in handling national and international regulatory requirements
• Experience providing technical leadership for complex projects and cross-functional interfaces
• Matrix or direct people-management experience is an advantage
• Strategic thinking combined with a structured and autonomous working style
• Strong communication skills when collaborating with internal departments and external partners
• Excellent German and English language skills

• A responsible position with scope to shape processes in 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
• A flexibly usable additional benefits budget
• Access to an employee discounts platform
• Company and team events