Regulatory Affairs Manager supporting approval and maintenance of medicinal products at Merz Therapeutics. Utilizing knowledge of global regulatory quality requirements and maintaining compliance standards.
Responsibilities
Apply knowledge of global regulatory and quality requirements to support the approval and maintenance of medicinal products
Create, review, and update high-quality CMC documentation to obtain and maintain product approvals, ensuring compliance with global regulatory requirements
Support the preparation of IMPDs for clinical trial applications
Implement change control processes, coordinate regulatory assessments, and maintain CMC submission and approval status
Manage inquiries related to quality documentation from regulatory authorities, ensuring timely and accurate responses
Oversee regulatory CMC projects, liaise with Merz representatives and partners, and coordinate third-party services
Develop regulatory CMC strategies and represent regulatory requirements within project and interdisciplinary teams
Maintain a detailed understanding of global and national CMC regulatory requirements and best practices
Requirements
Completed scientific degree in Pharmacy, Biology, Chemistry or a related field; a doctorate is an advantage
3–5 years' experience in regulatory affairs or in a department responsible for CMC matters (e.g., analytics, development, or quality control)
Analytical and systematic thinking
Strong negotiation skills and ability to work effectively in teams
Solution-oriented approach with a strong focus on compliance and quality
Strong communication skills, including excellent command of English
Benefits
Personalized career development in a purposeful role — you help improve the quality of life for our patients!
Hybrid working model that supports a good work–life balance
Attractive location with good transport links, modern workspaces and a company restaurant
Global family-owned business with flat hierarchies and an open, respectful corporate culture
Competitive remuneration with extensive social benefits
Variety of employer-subsidized benefits such as WellPass, Deutschland-Ticket, Corporate Benefits and JobBike
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