Regulatory Contractor
vor 2 Wochen
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
- 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
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