Regulatory Affairs Manager
2 weeks ago
PE Global is recruiting a Regulatory Affairs Manager (CTA) for our multinational pharmaceutical client based in Uxbridge. The role is hybrid and an initial 12-month contract.
In order to make an application, simply read through the following job description and make sure to attach relevant documents.
Responsibilities of the role:
Advising the GRT on regional considerations in developing strategyEnsuring the regional needs are well defined and implemented in collaboration with relevant regional stakeholdersMay manage one or more regional leads or support rolesMay 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.Under general supervision participates in core regulatory activities to ensure effective regional agency interactions.Review and approve materials for use in the EU.Strategy and Execution Plans and manage regulatory submissions.Implement product related regulatory strategies, Regulatory Affairs processes and activity planning.Manage in the development of the regional product label with the Labelling Working Group.Supports regional label negotiation activities, participate in the development and execution of regional regulatory product strategies.Requirements: Working with policies, procedures and SOPsKnowledge of relevant legislation and regulations relating to medicinal productsAwareness 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.Interested candidates should submit an updated CV.-
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