Regulatory Affairs Manager EU Remote

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Job Title: Regulatory Affairs Manager, EU, Oncology (Contract, Remote)

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, as well as Life Cycle Management for the European Centralised Procedures and clinical trial applications.

As Regulatory Affairs Manager EU Oncology, you will plan and track activities related to regulatory submissions in the EU, 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.

Seniority level

• Mid-Senior level

Employment type

• Contract

Job function

• Quality Assurance and Research

Industries

• Pharmaceutical Manufacturing and Biotechnology Research