EU Regulatory Affairs Manager - contract job
Your newpany
This well-known biotech is looking for an experienced Regulatory Affairs Manager to join their established EU Regulatory Affairs team. This is a 12-month contract job with scope for extension.This is a remote contract job with the need to go into the office once per month.
Your new role
As Global Regulatory Affairs Manager, you will support the creation of strategy and execution plans and manage regulatory submissions (, clinical trial and marketing applications) for products within the portfolio inpliance with global filing plans and local regulatory requirements.
As Global Regulatory Affairs Manager, you will take the lead role in advising the Global Regulatory team on regional considerations in developing strategy, as well as ensuring the regional needs are well-defined and implemented in collaboration with relevant regional stakeholders.
What you'll need to succeed
In order to be considered for this contract job as Regulatory Affairs Manager Global, you must have prior experience in the region of MAs, CTAs / post approval changes and amendments, extensions, and renewals. A strong working knowledge of EU CTR would be an advantage.
What you'll get in return
Remote working