Beschreibung
Senior Manager Regulatory CMC (m/f/d)
Reference: -en
Start: 01/22
Duration: 12 MM
Main tasks:
- Responsible for assessing and confirming the High Level impact assessment performed by Global CMC lead
- Responsible for updating the previously performed impact assessment
- Works closely with the Regulatory leads to ensure the agreed submission strategy is executed
- Manage, plan, and execute regional CMC regulatory submissions within the area of responsibility and ensure timely approvals throughout product development and lifecycle
- Provide direction to senior leadership, as relevant
- Develops and maintains effective working relationships with Cross-functional Teams; consultants and business partners as required
- Lead and provide regional regulatory input in due diligence for licensing opportunities, development and /or marketed products
Main qualifications
- BSc. Advanced scientific related degree preferred; BA accepted based on experience. Advanced degree preferred
- Experience within the pharmaceutical industry and including direct experience in CMC regulatory affairs in development and post-marketing phases for medicinal products
- Experience in CMC regulatory affairs for biological/biotechnological products
- Strong expertise in the EU region: CMC lifecycle maintenance
- Able to understand broad concepts within regulatory affairs and implications across the organization
- Experience managing relationships with CROs
Main advantages:
- A very renowned company
About us:
With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.
My contact at Hays:
My contact person:
Marc Peter Linder
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