Hobson Prior are currently working with a global biotechnology organisation who are seeking a UK CW Regulatory Affairs Manager to join them on a contract basis in Uxbridge or Cambridge. Our client focuses on transforming new discoveries and ideas into medicines for patients living with serious illnesses. As the Regulatory Affairs Manager you will support one or more products development and/or marketed products from a regional regulatory perspective.

Job Responsibilities:

• You will ensure that the organisation obtains and maintains all the required approvals in order to support clinical trials for investigational medicinal products as well as to market approved medicinal products.
• Ensure timely regulatory compliance with above approvals.
• Ensuring the regional needs are well defined and implemented in collaboration with relevant regional stakeholders.
• Advising the GRT on regional considerations in developing strategy.
• Contributing in core regulatory activities to ensure effective regional agency interactions consistent with the Global Regulatory strategy (under general supervision).
• Providing regulatory guidance on regional regulatory mechanisms to optimize product development.
• Participating as a member of: Global Regulatory Team, Evidence Generation Team, Clinical Study Team, Regional Teams.
• Representing as a contact with relevant regulatory agencies; documenting and communicating details and outcomes of regulatory agency interactions to GRT and relevant Management and Senior Management.

Requirements:

• Knowledge of relevant legislation and regulations relating to medicinal products and of regulatory procedures in region for MAs, CTAs, post approval changes and amendments, extensions and renewals.
• Knowledge of drug development.
• Working with policies, procedures and SOPs.
• Cultural awareness and sensitivity to achieve results across both regional country and international borders.

Apply now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.