Regulatory Affairs Manager - Vaccines (m/f/d)

REFERENCE NUMBER:

440560/1

MY DUTIES:

-Support regulatory activities related to the development, registration and life cycle management of vaccine candidates in Europe
-Manage assigned regulatory projects including support of dossier/Marketing Authorization Application (MAA) submissions and life cycle management for vaccine candidates in the region
-Responsible for regulatory oversight of assigned clinical trials conducted in the region
-Provide regulatory oversight for assigned projects, focused on non-clinical and clinical aspects of drug development/approval and associated regulations
-Close collaboration with the RAV Europe Region Head and Lead (and LOCs as applicable) to ensure alignment and regulatory strategy execution during file preparation, submission, review, approval and life cycle management
-In cooperation with key stakeholders and RAV Europe Region Head/Lead (and LOCs as applicable), responsibility for overall content, management, compilation and timely availability of CTD Module 1 regulatory components to the assigned region/countries, ensuring filings meet local regulatory requirements
-Actively participate as member of Global Regulatory Teams supporting products activities as assigned
-Manage specific projects as assigned, e.g. regulatory activities related to EMA Transparency policy and assigned clinical trials conducted in the region, such as Regulatory Affairs Vaccines TMF Oversight, and regulatory activities related to upload of study protocol and/or result information to EU databases/portals
-Responsible for assigned project/timeline planning and tracking of commitments. Responsible for communication of commitments to team members

MY QUALIFICATIONS:

-BS/advanced scientific degree preferred
-Profound regulatory affairs experience in the pharmaceutical industry
-Managing filings to EMA via Centralised Procedure resulting in first-time approval
-Vaccines and/or biologics experience is essential
-Participation in Global regulatory filing a plus

MY BENEFITS:

-Reputable company

ABOUT 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.

MY CONTACT AT HAYS:

My contact person
Yves Fabien Deschamps

Reference number
440560/1

Contact
E-Mail: [email protected]