Senior Manager - Regulatory Affairs EU Oncology, remote working
Your newpany
This well-known biotech is looking for an experienced Senior Regulatory Affairs Manager to join an established Regulatory Affairs team on a fully remote basis. This is a 12-month contract job with scope for extension.This role will support the oncology portfolio, consisting of clinical trials and both pre- and post-authorisation activities.
Your new role
As Regulatory Affairs Senior Manager (contractor), you will support roles Strategy and Execution Plans and manage regulatory submissions ( clinical trial and marketing applications) for products within the oncology portfolio inpliance with global filing plans and local regulatory requirements (EU markets).The Senior Regulatory Affairs Manager EU (contract) will implement product related regulatory strategies, Regulatory Affairs processes and activity planning in accordance with national legislation and regulatory requirements as well as leading the development of regional regulatory documents and meetings in accordance with GRT strategy.
What you'll need to succeed
In order to be considered for this contract job as Senior Regulatory Affairs Manager EU Oncology, you must have substantial experience working in EU Regulatory markets and those with oncology experience would be at an advantage.
What you'll get in return
Fully remote work available, infrequent travel to Uxbridge or Cambridge offices at pre-agreed times for critical business meetings. Office work available for those who prefer being on site