Senior Manager Regulatory Affairs

CK Group are recruiting for a Senior Manager Regulatory Affairs to join a biopharmaceutical company who are based in Uxbridge or Cambridge on a contract basis for 12 months.

Company:

Our client is committed to unlocking the potential of biology for patients suffering from serious illnesses 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 based in Uxbridge or Cambridge and offers hybrid/remote working.

Hourly Rate:

£48.92phr PAYE or £64.85phr Umbrella.

Role:

• To maintain 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.
• Advise the Global team on regional considerations in developing strategy ensuring the regional needs are well defined and implemented in collaboration with relevant regional stakeholders.
• Manage regulatory submissions (e.g. clinical trial and marketing applications) for products in compliance with global filing plans and local regulatory requirements.
• Implement product related regulatory strategies, Regulatory Affairs processes and activity planning in accordance with national legislation and regulatory requirements.
• Provide regulatory direction on regional regulatory mechanisms to optimise product development (e.g. expediting FIH studies, Orphan Drug, conditional/accelerated approvals, compassionate use and paediatric plan).
• Direct the development of the 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 regional label negotiation activities with minimal supervision and co-ordinate company responses to requests from regulatory authorities, e.g Response to Questions (RTQs).
• Manage core regulatory activities to ensure effective regional agency interactions consistent with the Global Regulatory strategy, includes contingency regulatory planning/risk assessment.

Your Background:

• Educated to degree level or above in Life sciences or a related field.
• Extensive experience in Regulatory Affairs across global markets and an understanding of the regional regulatory procedures for CTAs, MAAs, post approval changes, extensions and renewals.
• Excellent communication skills and experience of building relationships with stakeholders to achieve results across both regional country and International borders.
• Strong knowledge of relevant legislation and regulations relating to medicinal products.

Apply:

It is essential that applicants hold entitlement to work in the UK. Please quote job reference 102404 in all correspondence.