Director of Governance, Risk & Compliance overseeing technology and AI compliance at MTM Health. Leading regulatory alignment and governance for cloud and software development in a healthcare context.
About the role
- 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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