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Regulatory contractor

Maidenhead
Temporary
SRG
Posted: 14h ago
Offer description

Job Title: Regulatory Contractor Location: Maidenhead Contract: 12 Months Hours: 37.5 hours per week Rates: £25-30 p/h Job Description SRG are looking for a regulatory contractor to join a global pharmaceutical company based in Maidenhead. The Regulatory Contractor is responsible for providing global regulatory expertise for Clinical Trials. They are the primary interface between global functions and affiliates to deliver clinical development regulatory strategies, operations and outcomes. Duties and Responsibilities Manage a portfolio of CTAs including preparation and distribution of documentation associated with new initial CTAs and all CTA maintenance activities such as substantial amendments, end of trial notifications etc. Provide advice on submission strategy, country requirements, etc. as well as operational support for Regulatory submission preparation and processing of amendments. Review of and input on documents related to clinical trial submissions managed by other stakeholders such as IB, Protocols. Ensure approved company CTA processes are followed within agreed timelines. Good understanding of CTR process and requirements. Monitor key project milestones (actual vs. planned activities and timelines) and identify and communicate issues/changes to assigned stakeholders and management as agreed in company procedures. Support inspection readiness activities when applicable Review and maintain awaren...

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