Senior Director, Global Regulatory Affairs – Leading Biopharma

The Company:

New opportunity leading biopharma company who are currently in a phase of sustained growth due to impressive success of its development pipeline. To support this growth the company are now looking to recruit a Senior Regulatory Director to play a key role in late stage development activities.

The Role:

Reporting into the therapy area VP this role will play a pivotal role in bringing new cutting edge therapies to market. These positions are very strategically focused and incorporate both EU and fully global responsibility;

·      Planning and implementation of global regulatory strategy

·      Leading Health Authority interactions; Scientific Advice, Oral Defenses, Response to agency questions

·      Cross functional liaison with internal stakeholders; Commercial/Clinical/Medical

Background:

·      Minimum Requirement BSc. & further advanced degree preferred

·      Must have proven experience working with EU regulatory affairs with a good understanding of the global regulatory environment – Additional US experience would be preferred, but not essential

·      Demonstrable experience with late stage development activities – Ideally MAA submission involvement and interactions with HAs

Full information on this job is available upon application (see below). For more information on this or other Regulatory Affairs vacancies please contact Adam Griffin on; +44 (0)20 7096 0362 OR forward an up to date resume to adam.griffin@pharmappoint.net

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Keywords: Regulatory, Regulatory Affairs, Associate Director, Director, Senior Director, Regulatory Affairs, MAA, biopharma, pharmaceutical

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