One of my clients is urgently looking for a Regulatory Affairs Manager to join their team!
Job title: Regulatory Affairs Manager
Contract: 12 months
- To ensure that the company 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
- Provide management and leadership by supervising one or more other regional regulatory leads and/or support staff
- Advising the GRT on regional considerations in developing strategy
- Ensuring the regional needs are well defined and implemented in collaboration with relevant regional stakeholders
- Manage the product lifecycle for individual countries per national agency requirements
- 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 the company's portfolio in compliance with global filing plans and local regulatory requirements.
- 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
Michael Bailey International is acting as an Employment Business in relation to this vacancy.