Coordinator Regulatory Affairs CMC Biosimilars
Hobson Prior are working with a world-wide healthcare organisation whose products and services are used to help care for patients who are critically ill. Our client is looking for a Coordinator Regulatory Affairs CMC Biosimilars to join them on a permanent basis in Nyon, Switzerland.
- You will assist and coordinate the CMC regulatory activities and CMC submission of Biosimilar dossiers and submissions that best serve the biosimilars business needs.
- Initiate reviews of regulatory documents and organize consolidation meetings
- Act as timekeeper in the preparation of Biosimilar submissions.
- Manage, plan and organize any activity related to biosimilar CMC submissions, in coordination with other functions.
- Act as a safeguard in the completion of the relevant CMC documentation to allow timely submissions for the assigned products/countries.
- Act as an interface between Regulatory Affairs CMC team and other internal and external functions as appropriate.
- Coordinate activities between different stakeholders (internal & external) for the assigned projects.
- Formatting CMC dossier sections in line with the company's style guide
- Independently screen comments and prepare reviewed sections for consolidation.
- In charge of documentation management for the Regulatory Affairs CMC team.
- Any other assigned tasks.
- Excellent organizational and planning skills.
- Excellent multi tasking skills.
- Strong interpersonal skills.
- Excellent spoken and written English (a second major language would be an advantage).
- Degree in a Life Science or related discipline.
- A minimum of 3+ years in a project management role.
- Experience in highly regulated environment (i.e. pharmaceutical, medical device).
- Experience in preparation and coordination of regulatory submissions is a admirable.
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.
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