Regulatory Affairs Manager

12 month contract

EU Oncology

£58.19 per hour - inside IR35

UK - home based

Responsibilities:
• Advising EU regulatory considerations in developing strategy.
• Planning and managing regulatory submissions (CTA's and MAA's) for products within our client's portfolio.
• Leading development of EU regulatory documents and meetings.
• Providing regulatory direction on regional regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, PRIME, compassionate use and paediatric plans).
• Act as point of contact with the EMA.

Knowledge and Skills:
• 4+ years of EU Regulatory Affairs experience concerning the EU region including clinical trials (CTAs) and registration procedures (MAs, post approval changes, extensions and renewals).
• Good knowledge of and experience in regional regulatory environment in relevant product area and development stage
• Experience with RTQ's with EMA.

Please note this role sits outside of... regulatory CMC, so CMC experience is not relevant.

To apply for this role you must be based in the UK and have the right to work in the UK
England UK

Salary Criteria