Hobson Prior are looking for a Senior Regulatory Affairs Manager to join world-wide pharmaceutical organisation who are determined to bring better health to patients. This position will be based in Zurich.
In charge of supporting the regulatory activities related to the development, registration and life cycle management of vaccine candidates in Europe.
Manages given regulatory projects including support of dossier/MAA submissions and life cycle management for vaccine candidates in the region.
Ensures that all essential applications are filed and upheld in compliance with applicable regulations.
Provides regulatory operational support for allocated projects, focused on non-clinical and clinical aspects of drug development/approval and associated regulations.
Responsible for regulatory oversight of given clinical trials conducted in the region.
Works together with all regulatory counterparts to ensure configuration and completion of the global regulatory strategy for the assigned projects.
Leads and directs the work of others as part of a matrixed organization.
Capability to understand and interpret scientific issues across projects.
Pays 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.
Exceptional in working and communicating well with others.
Proactively identifies regulatory issues.
Offers creative solutions and strategies, including risk mitigation strategies as applicable.
Educated to a minimum of degree level, BSc- advanced scientific degree preferred.
A minimum of 6 years pharmaceutical industry experience.
At least 4 years 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 advantageous.
Prior participation in Global regulatory filing is beneficial.
If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.