Regulatory Affairs Manager

·Role: Regulatory Affairs Manager [12 Months]

·Client: Biopharma 

·Location: Hybrid – Two days per week onsite (West London or Cambridge)

What you will do…

Our client is a respected, international bio pharmaceutical organisation committed to accelerating treatments in areas of unmet medical needs.

Their work is predominantly focused on drug discovery and the development of ground-breaking medicines across 4 key areas.

What you’re accountable for…

You will be focused on the management of the ongoing/ new global clinical studies for development products in the inflammation area. 

You will have a keen eye for details with accuracy and quality, along with the ability to facilitate effective strategic planning interactions and discussions. 

Duties will also include maintaining a working knowledge of regulatory requirements and communicating changes to product teams and senior management. 

What you will need to have…

This role will support the Inflammation therapeutic area team with a focus manage global clinical studies. It is ESSENTIAL that you have extensive experience preparing and submitting regulatory documentation to support clinical trials. 

Knowledge of pre and post-licensing EU procedures, with experience working with document management systems. 

It is important that your experienced representing Regulatory Affairs on cross-functional teams. 

Additionally, you will have excellent oral and written English communication skills. 

What’s in it for you…

·VERY competitive Day Rate

·INCREDIBLE experience and exposure within a truly innovative organisation

·HYBRID working model with 2 days onsite per week

What you need to do to apply…

For more information reach out to Charlie Burnham at Umbilical… You can find Charlie on LinkedIn!