Senior Regulatory Affairs Associate (Full Life Cycle) - West London/Cambridgeshire - Use your full life cycle experience to gain a great insight into a fantastic biotech.
JOB SUMMARY:
i-Pharm Regulatory have a Senior Regulatory Affairs Associate position which will incorporate full life cycle activity. This position is assigned to a key therapy area which is very prevalent in the 21st century. The successful candidate will join a leading Biotech company that is growing year on year and making great strides in the Pharmaceutical sector.
RESPONSIBILITIES
i-Pharm Regulatory have a Senior Regulatory Affairs Associate position that will look at both clinical and post marketing Regulatory affairs. The position will involve the preparation of regulatory submissions for both investigational and commercial products assigned to the therapy area.
*Prepare applications/submissions via the European Centralised procedure to relevant health authorities (renewals, variations, PSURs etc)
*Ensure packaging and associated information is updated and maintained in accordance with the Marketing Authorisation.
*Prepare regulatory documentation to support Clinical trial Applications and to assist in MA applications.
The ideal candidate would have strong experience with around 2/3 years direct regulatory affairs experience. You will have experience of working within a Pharma/Biotech and have been involved in submissions in both clinical and post marketing settings.
TO APPLY
If you would like to discuss this vacancy further, please call i-Pharm Regulatory Team Leader Joe Balfour on +44 (0)20 3189 2299, or email jbalfour@i-pharmconsulting.com. If this role is not suitable, Joe is also available to discuss other possible positions or answer any general questions regarding your career and the current market.
ABOUT i-PHARM REGULATORY
i-Pharm Regulatory is a specialist Recruitment team working wholly within the Regulatory Affairs market. We provide both permanent and contract staff to a wide range of Pharmaceutical, Medical Device, Biotechnology and Contract Research Organisations (CROs). I-Pharm Regulatory is a team within the larger organisation i-Pharm consulting which provides candidates in areas such as: Clinical Operations, Pharmacovigilance, Biometrics, Project Managements, Quality Assurance and Health Economics. Visit our website to see our extensive current vacancies:
www.i-pharmconsulting.com
KEY WORDS
Regulatory affairs, senior regulatory affairs executive, senior regulatory affairs, clinical regulatory affairs, reg affairs, regulatory affairs manager, regulatory affairs senior manager, regulatory affairs director, development, regulatory affairs manager, regulatory intelligence, Cambridgeshire, Cambridge, Hertford, Hertfordshire, London, East of England, London, West London, Uxbridge, Maidenhead, Slough, Reading