!*Regulatory Affairs Manager - Remote/hybrid in Uxbridge - Global Biotech*!
Job details
!*Regulatory Affairs Manager - Remote/hybrid in Uxbridge - Global Biotech*! Location: Hybrid in Uxbridge (Can be homebased but will need to attend office when required) Length: 12 month contract - Company have average tenure of 5+ years Rate: Incredible rate FTE: Full time This role will support one or more products from a regional regulatory perspective. As a member of the Global Regulatory Team (GRT), they will achieve the desired labelling by developing and executing regional regulatory strategies and managing effective agency interactions. The purpose of this role is:
- To 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
- To ensure timely regulatory compliance with above approvals
- As requested this role may provide management and leadership by supervising one or more other regional regulatory leads and/or support staff (dependent on grade)
- 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
- 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
- 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.
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