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Regulatory Affairs Manager
Description:
++ Regulatory Affairs Manager : 12 month contract (inside IR35) ++ Within this role you will support one or more products from a regional regulatory perspective. As a member of the Global Regulatory Team, you will achieve the desired labelling by developing and executing regional regulatory strategies and managing effective agency interactions. The purpose of the role: : Ensure that the 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. : Ensure timely regulatory compliance with above approvals. : This role may provide management and leadership by supervising one or more other regional regulatory leads and/or support staff. Responsible for: : Advising the Global Regulatory Team on regional considerations in developing strategy : Ensuring the regional needs are well defined and implemented in collaboration with relevant regional stakeholders : May manage one or more regional leads or support roles : May participate as a member of: Global Regulatory Team (GRT) Global Development Team (GDT) Clinical Study Team (CST) Label Working Group (LWG) Regional Teams (e.g. IMT, IBT, NAMT) : Act as a contact with relevant regulatory agencies in fulfilling local obligations. : Participate in core regulatory activities to ensure effective regional agency interactions are consistent with the Global Regulatory strategy. : Region Specific Activities, EU: Review and approve promotional and non:promotional materials for use in the region EM: Manage the product lifecycle for individual countries per national agency requirements EM: Work through the regional leads to manage distributor markets. : Strategy and Execution Plans and manage regulatory submissions (e.g. clinical trial and marketing applications) for products within the client's portfolio. : Supports regional label negotiation activities and participate in the development and execution of regional regulatory product strategies, including precedence, risk management and contingency planning. Knowledge and Experience Required: : Working with policies, procedures and SOPs. : Knowledge of relevant legislation and regulations relating to medicinal products. : Awareness of the regulatory procedures in region for MAs, CTAs, post approval changes and amendments, extensions and renewals. : Knowledge of drug development Cultural awareness and sensitivity to achieve results across both regional country and international borders. For further details, Tim Barratt on +44(0)1727 817 626 or email
Posted:
April 30 on Tip Top Job
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