Regulatory Affairs Manager

MSI Pharma are looking to hire a CMC Regulatory Affairs Specialist for a UK based pharmaceutical firm. This is a contract role and can be worked fully remotely from anywhere in the UKResponsibilites:Manage the timely preparation (may include authoring) and delivery of CMC contributions to the regulatory submissions linked to medicinal products throughout the lifecycle; including clinical programs marketing authorisation applications and all post approval approval activities Accountable for delivering "submission ready" CMC modules to internal and external regulatory stakeholders in compliance with relevant systems and procedures and ensuring submission quality.Documenting maintenance and communication of Health Authority approval status.Develops and builds expertise in regional regulatory requirements to ensure assurance of compliance of CMC submissions.Project management expertise with the ability to adapt to changing situations to ensure on time delivery.Ensure the learning from own projects are shared with other colleagues/within the functions.Education and Experience:University degree in a science or technical field such as pharmacy, biology, chemistry or biological science.Breadth of knowledge of manufacturing, project, technical and regulatory management.Knowledge of the drug development process and regulatory submissions.Understanding of current regulatory CMC requirements Oncology Experience
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