Regulatory Contractor

Job Description

Regulatory Contractor – full-time 6 months contract (remote)

We are seeking a Regulatory Affairs Contractor to support one of our small biotech clients, including the preparation and submission of initial Marketing Authorization Applications (MAAs).

September start date

Fully remote, but preference to have candidates based in Spain, Poland or Switzerland.

Key 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

Required experience:

• Strong CTA and CTIS experience <...