TRIGA Consulting GmbH & Co. KG

Compliance

• 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

Senior Lead, Regulatory CMC