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Haybury
,
London, Greater London
Senior Associate Regulatory Affairs
Overview
A fantastic opportunity to work for a global leader in the pharmaceutical industry has become available on a 12-month contract in London, The UK. Our client is one of the world’s leading pharmaceutical companies, whose innovation and development has strengthened them as a global giant in their field. Their values are established in research and development and the utmost care for their consumers. The Senior Associate would work under the direction of a Regional Regulatory Lead and 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. You will assist and support all submissions, variations, MAA’s for clinical trials and lifecycle management. Responsibilities 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) 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) Provide regulatory support to Commercial, Medical and Clinical departments through cross-functional interactions in brand and therapeutic area teams Job Requirements EU regulatory experience Preparing and submitting CTAs applications. It would be a bonus if you have used the VHP. Coordinating response preparation Assisting in the preparation of post authorisation submissions. For example, variation applications, RTQs for centrally authorised products, or purely national products Must have a scientific background Good English written and spoken ability Excellent attention to detail Some familiarity with regulatory guidelines In return you will receive A competitive salary Opportunity to progress within the company The chance to be part of an innovative global leader If you are driven, team orientated and have the ability to work under pressure, contact Max today for further information on this opportunity. Max is a Search Consultant at Haybury Pharmaceutical Search covering Europe, UK, North America and Asia. This job was originally posted as www.totaljobs.com/job/89908709