Jobbeschreibung
As a Lead 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
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Completed scientific Studies in Pharmacy, Biology, Chemistry or a related field of studies, a doctorate is an advantage
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3-5 years in regulatory affairs or in a department responsible for CMC matters, such as analytics, development, or quality control
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Strong communication skills, including profound English
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Analytical and systemic thinking
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Strong negotiation skills and teamwork
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Solution-oriented with a focus on compliance and quality
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Individual career development in a purposeful job: you improve the quality of life of our patients!
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Hybrid work model that allows a good work-life balance
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Attractive location with good transport links, modern workplaces and a company restaurant (€4.13/menu)
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Global family business with flat hierarchies and an open, respectful corporate culture
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Attractive remuneration with extensive social benefits
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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.
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