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:

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