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Regulatory Affiars Advisor

Location Horsham

To assist the Head of Regulatory Affairs in the regulatory aspects of maintaining the product portfolio and developing new products. The product portfolio covers medicines, cosmetics, foodstuffs and medical devices

1. Compile, and assist in the compilation of administrative information and pharmaceutical, clinical and pre-clinical data and dossiers for submission, after internal approval, to the UK and Irish Licensing Authorities in order to obtain identified new product licences, licence variations, licence renewals, clinical trial certificates and variations, in accordance with accepted regulatory standards. Assist in the liaison with the regulatory authorities, answering questions and supplying further data as required.

Paquete Trabajo

29K (may go more for right person) basic
Single BUPA, 10% bonus, Money Purchase Pension

Perfil Personal

Degree in life sciences, pharmacy or chemistry.
1 year's plus regulatory affairs experience within a pharmaceutical/healthcare industry
Good verbal and written communications skills
Knowledge of EU and UK laws
Commercial awareness
Capable of handling and understanding scientific information

An ability to understand and interpret governmental regulations/guidelines and apply them so that regulatory requirements are met.

The ability to communicate effectively with the FDA and other Regulatory Agencies.

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