Regulatory Affairs Manager - Uxbridge - 12-Month Contract
Our client, a globally recognised pioneer in Biotechnology, is 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 strive for solutions. This is your chance to join them on their global mission to better the lives of those affected 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 senior management Under general supervision, participates in core regulatory activities to ensure effective regional agency interactions consistent with the Global Regulatory strategy, including 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
Strategy and Execution: Plans and manages regulatory submissions (e.g., clinical trial and marketing applications) for products within portfolio in compliance with global filing plans and local regulatory requirements.
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!
#J-18808-Ljbffr
Our client, a globally recognised pioneer in Biotechnology, is 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 strive for solutions. This is your chance to join them on their global mission to better the lives of those affected 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 senior management Under general supervision, participates in core regulatory activities to ensure effective regional agency interactions consistent with the Global Regulatory strategy, including 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
Strategy and Execution: Plans and manages regulatory submissions (e.g., clinical trial and marketing applications) for products within portfolio in compliance with global filing plans and local regulatory requirements.
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!
#J-18808-Ljbffr
