Responsible for supporting the regulatory activities related to the development, registration and life cycle management of vaccine candidates in Europe
Manages assigned regulatory projects including support of dossier/Marketing Authorization
Application (MAA) submissions and life cycle management for vaccine candidates in the region
Ensures that all necessary applications are filed and maintained in compliance with applicable regulations
Provides regulatory operational support for assigned projects, focused on non-clinical and clinical aspects of drug development/approval and associated regulations
Responsible for regulatory oversight of assigned clinical trials conducted in the region
Collaborates with all regulatory counterparts to ensure alignment and execution of the global regulatory strategy for the assigned projects
Passion for quality in all areas of responsibility
Leads and directs the work of others as part of a matrixed organization
Ensures compliance with both internal process and policy and with regional regulatory requirements all with a focus on quality and accuracy in verbal and written communication
Bachelor, advanced scientific degree preferred
Profound pharmaceutical industry experience, with regulatory experience
European regulatory experience is essential. Preferred experience in managing filings to EMA via Centralised Procedure resulting in first-time approval
Vaccines and/or biologics experience is preferred
Participation in Global regulatory filing is a plus
Understands and interprets scientific issues across projects as the issues relate to regulatory requirements and strategy
Ability to pay strong attention to quality, and is working reliably and thoroughly
Strong in all basic skills sets such as oral and written communications (in English), managing and adhering to timelines, negotiation skills, integrity and adaptability
Exceptionally strong in working and communicating well with others including global, regional and local teams as well as cross-functional teams; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies as applicable
A very renowned pharmaceutical company
Pleasant working atmosphere
Über Hays: 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.
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