Senior Regulatory Affairs Officer

Date Posted: Monday, November 12, 2007

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Senior Regulatory Affairs Officer Dublin, Ireland 48-55,000 Euros + bonus + excellent pension + private health

This is an opportunity for a regulatory affairs professional with a proven track record in clinical research regulatory affairs. With your expertise, you will provide regulatory consultancy to clinical trial teams, develop regulatory strategy and negotiate with regulatory authorities.

This is a high profile role in a well established and rapidly expanding company. The senior regulatory affairs officer will have a variety of responsibilities including managing the regulatory aspects of multiple large-scale clinical trials, developing regulatory strategy and negotiating with sponsors and regulatory authorities.

Your in-depth knowledge and understanding of the law and clinical trial regulations will enable you to interpret legislation, challenge regulatory authorities and persuade them to your point of view. You will also provide consultancy to colleagues, senior managers and key sponsors; this could be on operational matters or problematic or unusual protocols. You will also mentor and provide training to junior colleagues. It is likely you will have an area of specialist knowledge and expertise (eg biologicals, chemistry, toxicology) and you will be able to act as an expert resource of information on this area.

This is a diverse and challenging role offering the right person the opportunity to play the lead role and influence the regulatory affairs of major clinical trials taking place across 20 + countries. Ideal candidates will have in-depth knowledge and experience of regulatory affairs in clinical research. You may work for a biotech, pharmaco or CRO and now be looking to use your experience and knowledge in a more challenging environment. In addition to your clinical regulatory expertise, you will have strong project management and consultancy skills, be a confident negotiator and able to act as an expert resource in your specialist area of knowledge. An excellent opportunity.

Key Skills: regulatory affairs, reg affairs, clinical trials, medical writing, scientific writing, regulations, dossiers, submissions, regulatory strategy, negotiation, project management, Investigator Brochures (IB), Investigational Medicinal Product Dossiers (IMPD), Investigational New Drug Applications (IND), Clinical Trail Applications (CTAs), Good Clinical Practice (GCP), ICH.

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

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