Description
Global Regulatory Affairs - Biosimilar Support (m/f)
Reference: -en
Start: asap
Duration: 5 MM
Main tasks:
- Assist in preparation and execution of global regulatory strategies defined for three biosimilar projects in partnership with an external pharmaceutical company.
- Coordinate regulatory activities between regulatory affiliates, reg. CMC and partner company with the view of submitting regulatory dossiers in specific geographies: USA, Europe, Brazil, Switzerland, and Australia.
- Coordinate the regulatory activities performed by Merck in support of three projects including management and coordination of the preparation of all regulatory documentation at different regulatory milestones.
- Support the partner regulatory function in coordinating Merck regulatory inputs and supportive activities.
- Support transition of regulatory activities between Merck and Partner company.
- Oversee of the regulatory agency interactions, document preparation, co-ordination rehearsals and minutes.
- Support Merck regulatory CMC participation to the CMC and Devices subteam.
- Prepare and support Merck regulatory participation within clinical, safety and regulatory workstream.
Main qualifications
- Degree in a Life Science or related discipline, higher degree preferable (PhD, MSc, MBA)
- Interest into Scientific details
- Knowledge of international regulatory affairs
- Prior exposure to Regulatory Affairs preferably in a global position
- Profound industry experience
- English (business fluent)
Main advantages:
- 20 % on-site support and 80 % remote
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:
Silvia Charro Lopez
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