Regulatory Affairs Manager (CTA/ CTR)

Job Title: Regulatory Affairs Manager (CTA/ CTR)

Job Type: Permanent, full-time

Locations: UK – Remote based with occasional travel

Regulatory Affairs Manager opportunity working for a cutting-edge Oncology focused global clinical research organisation conducting early- and late-phase oncology trials in the US, Europe, and Asia.

In this role, you must be based in the UK and will have the flexibility to be 100% remote. The position will be focused on Regulatory CTA/ CTR, amendments and end trial notifications for multiple projects and communicating effectively with clients according to business needs

Role responsibilities

• Provides strategic regulatory input to all assigned projects.
• Management, preparation, assembly of the Master Core Dossier and submissions of European.
• Clinical Trial Authorisation Applications (CTAA) and amendments.
• Country-level Informed Consent and oth...