Senior Manager CTA Submissions

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DETAILS: Full-time contract position ASAP start for minimum 12 month contract Remote working in the UK Competitive hourly rate of pay Global pharma company THE ROLE: Provides an interface to Regulatory and partners within designated Business Units, offering project leadership and expertise in the logistics involved with execution of regulatory CTA submissions to regional partners and selected Health Authorities. Drives global submission management activities for their assigned assets. Partners with product teams and/or third-party partners, with responsibility for representation and management of required regulatory activities, standards and deliverables associated with CTA submission development and execution for designated assets and/or geographies. Key participant and member of development teams and relevant meetings to advocate realistic deliverable timelines, understand project strategy, and assess associated impact and present status of global submission delivery activities Support and leads global team efforts to ensure high quality components and submissions that are compliant with industry, agency and format guidelines, regulatory strategies, policies, and timelines. Full job description available on application THE CANDIDATE: B.S./B.Sc is in Pharmacy or Life Sciences In-depth understanding and proven execution of CTA processes globally Strong knowledge of the drug development process, regulatory affairs, Clinical Trial Applications and submissions management. Comprehensive understanding of ICH/GCP & EU Clinical Trial Directive Understanding of EU Clinical Trial Regulation Desirable Only candidates with existing right to work in the UK/EU will be considered This job was originally posted as www.totaljobs.com/job/92266809

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