Regulatory Manager / Senior Regulatory Manager (Clinical Trials) job opportunity at Precision Medicine Group.

Home Jobs In United Kingdom Tag: Managing Regulatory Manager / Senior Regulatory Manager (Clinical Trials) position at Precision Medicine Group


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Precision Medicine Group Regulatory Manager / Senior Regulatory Manager (Clinical Trials)
Experience: 5-years
Pattern: full-time
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Status:

Managing

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degreeBachelor's (B.Sc.)
United Kingdom

Provides #regulatory guidance throughout the clinical development life cycle Compile, coordinate and review applications to Regulatory Authorities including, but not limited to, #CTA/IND, annual reports, routine amendments, scientific advice/regulatory authority meetings, orphan #designations, paediatric planning, and marketing applications. Also provides strategic regulatory input as required Develops and/or reviews documents intended for submission to the Regulatory Authorities and/or Ethics Committees to assure compliance with regulatory standards Serve as representative of #Global Regulatory Affairs at project team meetings with both external and internal customers Works within a project team, and where necessary, leads project for the region or globally Oversee and coordinate Regulatory Affairs Specialists to achieve submission targets for contracted programs Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership updated. Assist in development of Regulatory Affairs #Specialists and other operational area staff, as required Provide input, as required, into regulatory strategy and timeline development for new study opportunities Assists in establishing company standards to ensure the highest quality of submitted information Participates in #maintaining and executing on the corporate quality initiatives across business units within clinical solutions. Keeps abreast and continually expand knowledge of laws, regulations and guidelines governing drug development and approval Provides ICH #GCP guidance, advice and training to internal and external clients Serve as representative of Global Regulatory Affairs at business development meetings

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