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ETeam Inc
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Cambridge, Cambridgeshire
Senior Associate Regulatory Affairs
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Salary: £15 per hour |
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Overview
Job Title: Senior Associate Regulatory Affairs Job Location: Cambridge, Uxbridge, UK Job Duration: 12 Months The Regulatory Professional under the direction of a Regional Regulatory Lead will assist in the creation and submission of regulatory documents and may be the regulatory lead for a program under the supervision of a more experienced regulatory lead. Assist Regional Regulatory Lead to support regional regulatory pre-filing activities (e.g. core CTA/IMPD development and submission, support for pre-MAA filing, regulatory authority meeting preparations) Provide and maintain CTA/MA documentation support (e.g. variations, substantial amendments, PDCO annual reports) in collaboration with Regional Regulatory Lead Create and maintain product regulatory history documents through IMR/rRISE and appropriately archive all regulatory documents and agency communications Review regional component of the Global Regulatory Plan and provide input to operational deliverables Ensure compliance via timely submissions to regulatory agencies Support RRL in review of promotional materials for commercial activities (ex-US) Collaborate with CROs / partners to support site initiation Coordinate collection of functional documents in support of regulatory applications As appropriate participate in GRT to support execution of regulatory strategy Coordinate QC of regulatory documentation (e.g. briefing packages) Provide primary authorship to routine regulatory correspondence (e.g. annual reports, investigator packages) Prepare regulatory packages and cross-reference letters to support investigator initiated studies Approve drug shipment for Client and Investigator Initiated Studies Complete regulatory forms to support agency communications (E.G. EudraCT,) Provide regulatory support to Commercial, Medical and Clinical departments through cross-functional interactions in brand and therapeutic area teams Support process improvement initiatives, standards development, and metrics Assist in template development and maintenance Respond to specific requests from and communicate relevant issues to GRT Develop Regulatory Position with teams Actively support regulatory compliance Support the development and execution of GRT goals Key Skills Strong communication skills - oral and written Organizational skills Understanding of drug development process