YOUR CONTRIBUTION

As a Regulatory Affairs Manager (m/f/d) CMC, you will apply your knowledge of global regulatory quality requirements to support the approval and maintenance of medicinal products. This will include the following activities:

CMC Documentation: Create, review, and update high-quality CMC documentation to obtain and maintain product approvals, ensuring compliance with global regulatory requirements; support the creation of IMPDs for clinical trial applications

Change Control: Implement change control processes, coordinate regulatory assessments, and maintain CMC submission and approval status Response Management: Handle and manage inquiries related to quality documentation from authorities, ensuring timely and accurate responses Project Coordination: Oversee regulatory CMC projects, communicate with Merz representatives and partners, and coordinate third-party services Regulatory Strategy: Develop regulatory CMC strategies and represent regulatory requirements in project teams and interdisciplinary teams
• Regulatory Intelligence: Maintain a detailed understanding of global and national CMC regulatory requirements and best practices

• Individual career development in a purposeful job: you improve the quality of life of our patients!

• Hybrid work model that allows a good work-life balance

• Attractive location with good transport links, modern workplaces and a company restaurant (€4.13/menu)

• Global family business with flat hierarchies and an open, respectful corporate culture

• Attractive remuneration with extensive social benefits

• Variety of employer-subsidized benefits such as WellPass (€17.90/month), Germany ticket (10€/month), Corporate Benefits and JobBike

Find our more about our benefits here.