Regulatory Affairs Manager

2 days ago

Greater London, United Kingdom Quanta part of QCS Staffing Full time

Regulatory Affairs Manager - Greater London - Life Science - 12-Month Contract  Our client, a globally recognised pioneer in Biotechnology, are recruiting for the position of Regulatory Affairs Manager. A leader in the industry, our client focuses on areas of high unmet medical need and leverages its expertise to stride for solutions. This is your chance to join them on their global mission to better the lives of those effected by disease and illness. Responsible for: Advising the GRT 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 by product assignment Document and communicate details and outcomes of regulatory agency interactions to GRT and relevant sr. management Under general supervision participates in core regulatory activities to ensure effective regional agency interactions consistent with the Global Regulatory strategy includes contingency regulatory planning/risk assessment Knowledge and Skills Regulatory principles: 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. If this role is of interest to you, please apply now  #LI-KT1

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