Regulatory Affairs Manager (m/f/d) CMC
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
YOUR PROFILE
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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
YOUR BENEFITS
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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.
ABOUT US
Welcome to Merz Therapeutics, a leading pharmaceutical company that helps people with movement disorders, neurological diseases, liver diseases and other health conditions regain their quality of life.
We are proud to be a family-owned and value-driven company that has been dedicated to serving the needs of our patients for 110 years and is now a global innovation leader with products in more than 90 countries.
Our goal is to use our products to improve treatment outcomes for patients around the world, thereby reducing the burden of suffering for affected people and their surroundings.
Our dedication and commitment to relentless research and development is to ensure that unmet patient needs are identified and appropriate treatments are provided.
Therefore, become part of our international and motivated Merz Therapeutics family now and help us achieve our goal: "BETTER OUTCOMES FOR MORE PATIENTS"
For more information, visit https://www.merztherapeutics.com/.
