Regulatory Affairs Manager, EU, oncology, contract job, remote, EU CTR

Regulatory Affairs Manager EU contract job, oncology
Your new company

This global biopharmaceutical company is looking for an experienced Regulatory Affairs professional to join them on a contract basis. A 12-month, remote contract job with scope for extension.

Your new role

As Regulatory Affairs Manager, you will work closely with the EU Regulatory Lead within the oncology team, managing the operational and procedural aspects and providing support for new Marketing Authorisation Applications’ preparation and filings and also Life Cycle Management for the European Centralised Procedures as well as clinical trial applications.

As Regulatory Affairs Manager EU Oncology, you will plan and track activities related to regulatory submissions in the EU as well as communicate regulatory submission dates, regulatory status, nature of changes, and track and inform of minor/significant product information changes to all relevant parties.

What you'll need to succeed:
Previous experience working in Regulatory Affairs and a strong working knowledge of EU regulations. It is essential that all those Regulatory Affairs professionals applying for this position have worked directly with EMEA on different types of submissions as well as having clinical experience.
Strong EU CTR knowledge is essential.