• Senior Regulatory Affairs Officer
• Based in Worthing, West Sussex
• Broad Reg Affairs experience essential, including dossier compilation, change control, label reviews, licence updates and renewals.
• 12-month contract until end of 2010 (good chance of extension, possibly permanently)
• Salary up to £35,000 (on company’s payroll for duration of contract, with benefits)
• Immediate start preferred

Summary

An exciting opportunity for an experienced Regulatory professional, working with innovative Vaccines and an extensive European clinical pipeline. This is a fixed-term contract until at least the end of 2010.

The Company

A pioneering Europe-based Pharmaceutical company specialising in the treatment and prevention of allergies. Their unique focus is on the vaccination and prevention of conditions such as hay fever and asthma, and their groundbreaking work has recently been in the UK press.

The Role

Based in a fairly quiet but busy office, you will be responsible for contributing to activities across the department. This will include contributing to regulatory dossiers for submission to the European market at the end of 2010, reviewing CTA / IND submission and maintenance documentation, material labels, New Product Licenses, variations, renewals, assessing Change Controls, providing input for PSURs and signing off promotional material for regulatory compliance.

The company produces complex, life-changing vaccines based around live APIs. You will therefore need to quickly understand the scientific intricacies of these products, making this a challenging, fascinating and extremely fulfilling role.

Experience

The successful candidate will have a life science background (ideally to degree level), followed by extensive relevant experience gained in a Pharmaceutical Regulatory Affairs environment. You will need to have a good understanding of the drug development process and be able to demonstrate clear examples of your ability to assimilate information, perform critical analysis of regulatory documentation and prioritise your time effectively. Experience of the CTD format and its respective modules would be a strong advantage.

You must be someone who has conviction in their decisions, with good communication and negotiation skills.

Keywords

CTD, Reg Affairs, Regulatory Affairs, eCTD, Drug Safety, Clinical Safety, PSUR, Clinical Trial, Pharmacovigilance, MHRA, FDA, Project Management

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