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Regulatory Affairs Manager (m/f/d) CMC
Zusammenfassung
Ein führendes Pharmaunternehmen sucht einen Regulatory Affairs Manager (m/w/d) zur Unterstützung der Genehmigung und Verwaltung von Arzneimitteln. Sie sind verantwortlich für die Erstellung von CMC-Dokumentationen und die Koordination regulatorischer Abläufe. Bewerber sollten über ein abgeschlossenes Studium in Pharmazie, Biologie oder Chemie verfügen sowie 3-5 Jahre Erfahrung im Bereich Regulatory Affairs. Stellenangebote bieten ein hybrides Arbeitsmodell und umfangreiche Sozialleistungen.
Leistungen
Qualifikationen
- 3-5 Jahre Erfahrung in Regulatory Affairs oder CMC relevanten Abteilungen (Analytik, Entwicklung, Qualitätssicherung).
- Doktorat von Vorteil.
Aufgaben
- Erstellung, Überprüfung und Aktualisierung von CMC-Dokumentationen zur Genehmigung und Aufrechterhaltung von Produkten.
- Koordination regulatorischer Bewertungen und Management von Anfragen zu Qualitätsdokumentationen.
Kenntnisse
Ausbildung
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. The position is limited to 3 years and includes the following activities:
- 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
- Implement change control processes, coordinate regulatory assessments, and maintain CMC submission and approval status
- Handle and manage inquiries related to quality documentation from authorities, ensuring timely and accurate responses
- Oversee regulatory CMC projects, communicate with Merz representatives and partners, and coordinate third-party services
- Develop regulatory CMC strategies and represent regulatory requirements in project teams and interdisciplinary teams
- Maintain a detailed understanding of global and national CMC regulatory requirements and best practices
YOUR PROFILE
- Completed scientific Studies in Pharmacy, Biology, Chemistry or a related field of studies, a doctorate is an advantage
- 3-5 years in regulatory affairs or in a department responsible for CMC matters, such as analytics, development, or quality control
- Analytical and systemic thinking
- Strong negotiation skills and teamwork
- Solution-oriented with a focus on compliance and quality
- Strong communication skills, including profound English
YOUR BENEFITS
- 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
- 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, Deutschland-Ticket, Corporate Benefits and JobBike
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 proudto 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 goalis 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 commitmentto 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, visithttps://www.merztherapeutics.com/.
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