Büchi Labortechnik

Regulatory Affairs Specialist

Date Posted: Thursday, October 25, 2007

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Regulatory Affairs Specialist, Manchester, £34,000 region + bens

We have an urgent requirement for a pharmaceutical or biotechnology Regulatory Affairs Specialist.

Our client is an innovative biotechnology company that is targeting an unmet multi-billion dollar global market for its drugs.

They have an extensive research and development programme with drug candidates in both clinical trial and pre-clinical phases and have a marketing partnership with a global large pharmaceutical company.

The Regulatory Affairs Specialist will be responsible for the regulatory requirements of the company's R&D and clinical trial programmes.

You will prepare and submit regulatory dossiers and submissions for clinical trials (IND, CTA, IMPD, IB), pre-clinical research and as the products progress, for marketing authorisations (MAA, NDA, ANDA).

You will provide regulatory information, training, guidance and support to all departments and ensure all research is compliant with current regulations and legislation.

This will be a diverse and challenging role offer opportunity to gain experience of a wide range of dossiers and submissions. Ideal candidates will be experienced Regulatory Affairs professionals looking for a diverse and challenging role.

You will have experience of electronic dossier submission (e-CTD) and a sound knowledge of regulation for clinical and research. An excellent opportunity.

Keyskills: regulatory affairs, reg affairs, clinical trials, pharmaceutical, biotechnology, regulatory, regulations, registrations, submissions, compliance, dossiers, CTA, CTC, IND, IMPD, IB, NDA, ANDA, MAA, CTD, e-CTD.

VRS Regulatory is the Regulatory Affairs division of specialist scientific recruiter VRS. Founded by consultants with Recruitment and Regulatory Affairs knowledge, we have rapidly become a leading force in Regulatory Affairs Recruitment Solutions.

For further details contact John Sherratt: VRS Regulatory DL: +44 (0) 161 976 2825 jsherratt@vrs-regulatory.net

Further Information: http://www.vrs-regulatory.net