Your new company
A multinational pharmaceutical company is looking for a Regulatory Contractor on a portfolio basis to support them with their busy portfolio for EU markets.
Your new role
You will be part of the team that manages the procedural and operational aspects of the EU regulatory fillings with the EU CP, working in close collaboration with the EU Regulatory Liaison group and local affiliates. Your responsibility in this team will be to:
- Manage the operational and procedural aspects to support new MAA preparations and filings, also Life Cycle Management for EU CP.
- Work directly with the EU Strategist to support implementation of the regulatory strategies across all products
- Plan and track activities related to the submissions
What you'll need to succeed
- Previous experience working on LCM and MAA with minimal supervision, supporting early projects, scientific advice (preference), and taking a leadership role for non-project based support.- Minimum of 4 years of experience in Regulatory Affairs
- Previous experience managing projects
What you'll get in return
This is an initial 12-month contract with scope for extension. You will be able to work across a very large portfolio of products throughout the drug development lifecycle, so this role may give you the exposure you need to expand on your current experience.
What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
If this job isn't quite right for you, but you are looking for a new position, please contact Julia Bowden, Business Manager, Interim Regulatory Recruiter.