Regulatory Affairs Senior Manager

CK Group are recruiting for a Regulatory Affairs Senior Manager to join a biopharmaceutical company. You can be based from either Uxbridge or Cambridge, with regular team meetings 2 to 3 times per month. This role is for 12 months, and is determinedas inside IR35, and allows for Remote working for the majority of the time.

Rates:

Hourly: Up to £80.00 Umbrella / £60.00 PAYE

Company:

Our client is committed to unlocking the potential of biology for patients suffering from seriousillnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Location:

The role is remote based position but the office team location is Uxbridge and Cambridge. Ideally you should be able to travel into the office occasionally for meetings, roughly two to three times a month.

Regulatory AffairsManager:

Ensure that the company acquires and maintains all the required licenses in order to support clinical trials for investigational medicinal products as well as to market approved medicinal products to ensure timely regulatory compliance with above approvals.

Responsibilities:

• Advising on regional considerations in developing strategy ensuring the regional needs are well defined and implemented in collaboration with relevant regional stakeholders.
• Direct the development ofthe regional product label by collaborating with the Labelling Working Group to define commercial objectives in the context of available and expected scientific data, regulatory guidance and precedent.
• Manage regulatory submissions (e.g. clinicaltrial and marketing applications) for products within the portfolio in compliance with global filing plans and local regulatory requirements.

Experience Required:

• Strategic guidance on filing strategies.
• EU market/working with global teams.
• Early development experience, with taking a product to market.
• Post approval experience.
• Pediatric plans and scientific advice.

Oncology experience is also a pre-requisite.

Apply:

It is essential that applicants hold entitlement to work in the UK. Please quote reference 56283 in all correspondence.