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Job type: Contract

Discipline: Senior/Director & VP

Location: Switzerland

We are seeking a Regulatory Affairs Consultant, including the preparation and submission of initial Marketing Authorization Applications (MAAs).

Please note that to be considered for this role you must have the right to work in this location or hold an EU passport.

Responsibilities:

Lead or support EU regulatory submissions, including CTA applications and amendments via CTIS
Centralised MAAs for New Active Substances (NAS)
Authoring/preparing Paediatric Investigation Plans (PIPs), waivers and modifications
Supporting preparation of scientific advice meetings
Support in monitoring, assessing, and maintaining current awareness of evolving regulations and guidance documents relevant to ongoing studies

Key Skills and Requirements:

Strong CTA and CTIS experience
Proven experience authoring/leading PIP's
MAA filing/submission experience
Strong understanding of EU regulatory landscape and clinical trial regulations including scientific advice, meetings with EMA and national HA's
Oncology experience is desirable

If you are having difficulty in applying or if you have any questions, please contact Peter Duvall at p.duvall@proclinical.com.

Apply Now:

If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.

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