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ETeam Inc
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Cambridge, Cambridgeshire
Regulatory Affairs Manager
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Salary: £43 per hour |
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Overview
Job Title: Regulatory Affairs Manager Job Location: Cambridge, Uxbridge Job Duration: 12 Months This role will support one or more products development and/or marketed products from a regional regulatory perspective. The purpose of this role is: • To ensure that Client acquires and maintains all the required approvals 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 The role may be responsible for: • Advising the GRT on regional considerations in developing strategy • Participating 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 (e.g. expediting FIH studies, Orphan Drug, conditional/accelerated approvals, compassionate use and paediatric plans) • Ensuring the regional needs are well defined and implemented in collaboration with relevant regional stakeholders • Participating as a member of: Global Regulatory Team (GRT), Evidence Generation Team (EGT), Clinical Study Team (CST), Regional Teams • Acting 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 Knowledge and Skills: • 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