Description:
In this role, you must be based in the UK, Italy, Spain, Ireland, or Sweden 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 other patient facing documentation
- Tracks, reports and files CTAA and amendment submissions / approval progress in electronic trial master files (eTMF) clinical trials management system (CTMS) or other applicable systems.
- Supports clients in preparing for advice meetings with national RAs or the European Medicines Agency.
- Maintains an awareness of the literature on cancer therapy, clinical trial design and conduct, Good Clinical Practice, and regulations and guidelines relating to the conduct of clinical trials produced by IECs and CA’s.
- Supports Regulatory Director in business development activities including the preparation of client proposals and bid defense meetings.
- Provides regulatory training to other members of the team as required
Qualification requirements
- Bachelor’s degree required preferably in a life science field or equivalent.
- At least 2-5 years of industry experience in a regulatory role required.
- Prior experience in a CRO/pharmaceutical environment required.
- Ideally previous experience working on EU CTR submissions.
- Previous Oncology experience.