Büchi Labortechnik

Senior Regulatory Affairs Officer

Date Posted: Monday, November 12, 2007

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Senior Regulatory Affairs Officer Scotland - Borders/Central £32-38,000 + excellent bens We have an opportunity for a regulatory affairs officer to move into a role with exposure to the full regulatory lifecycle. You will be supporting projects from pre-clinical all the way to post registration maintenance. If you feel pigeon holed and would like to gain experience of the full regulatory life cycle and, join a friendly team happy to share knowledge and experience, then this may be for you.

This company is a fast growing European wide organisation with their own portfolio of diverse products. Their R&D portfolio has compounds at pre-clinical, clinical phases I, II and III and they have numerous marketed products with successful and expanding sales. They have a number of collaborations with external research groups and large pharma and plan to continue their aggressive expansion.

The diversity and nature of this activity means the regulatory affairs team is busy and expanding. They are looking for someone who is happy taking responsibility for their own projects, who likes challenge and diversity, can learn quickly and who is happy to share knowledge. You will be involved in diverse projects at all stages of the regulatory life cycle; defining regulatory strategy, compiling data, reviewing dossiers, preparing dossiers (IMPDs, IBs, CTAs, NDAs, MAAs) and providing advice and consultation to colleagues and management.

You will join a dynamic, busy and friendly team and see the direct impact of your work. To be eligible for this role you are likely to have a successful track record in regulatory affairs with a CRO, pharmaceutical, biotech company or regulatory agency. You will have strong knowledge of EU legislation and regulation, experience of dossier review and preparation and a broad understanding of the drug development process. You will have excellent communication skills, be flexible and happy to learn new ideas and approaches. This is an excellent opportunity - contact VRS Regulatory for further details.

Key Skills: regulatory affairs, reg affairs, registrations, post registration, maintenance, MAAs, marketing authorisations, variations, renewals, clinical trials, CTAs, pharmaceutical.

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