Regulatory Affairs Officer

Date Posted: Monday, November 12, 2007

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Regulatory Affairs Officer Dublin, Ireland 37-43,000 Euros + Bens

We are looking for a regulatory affairs officer with 6-12 months experience to join an expanding regulatory affairs department. The company runs large-scale worldwide clinical trials for new pharmaceuticals and biologics; the regulatory team is responsible for all regulatory aspects.

Working with senior regulatory colleagues, the role involves providing regulatory guidance to the clinical trial team. This will involve interpretation of regulations, gathering and formatting data, scientific / report writing and assisting in the compilation of dossiers including Investigator Brochures (IB), Investigational Medicinal Product Dossiers (IMPD), Investigational New Drug Applications (IND) and Clinical Trail Applications (CTAs).

You will have responsibility for individual trials and be the regulatory point of contact for colleagues and sponsors. You will work closely with senior colleagues who will provide expert input and advice for your projects. This is an excellent opportunity to take a high profile and exciting role and really expand your regulatory knowledge.

Suitable candidates must have 6-12 months experience of regulatory affairs in a clinical research or clinical trails environment or considerable experience in another regulatory area combined with knowledge of clinical trials. You will have a good knowledge of clinical trail legislation and regulations and be familiar with the structure and content of clinical trail regulatory dossiers. Outgoing and confident communication skills are essential along with high levels of motivation, organisation and an eye for detail. Proven scientific or medical writing skills would be a major benefit.

Key Skills: regulatory affairs, reg affairs, clinical trials, medical writing, scientific writing, regulations, dossiers, submissions, 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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