Job Description Regulatory Affairs Manager (Clinical Trial-EU)- Berkshire/West London – A surprisingly impressive opportunity for an experienced Regulatory professional to make that step up into management.

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JOB SUMMARY:
A position has come available to join my clients well established and dynamic regulatory affairs team. The Regulatory Affairs Manager position will be part of the EU development team and provide input of global regulations for the clinical trial setting.

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RESPONSIBILITIES

i-Pharm Regulatory has an exciting role with a leading Pharmaceutical company. The successful candidate will be part of the development team within the EU and help to give advice and guidance on clinical submissions.

• Ensure planned drug development activities comply with EU regulations, providing analysis and risks for when they don’t
• Supports the preparation of core files for clinical trials
• Ensure global teams are provided with clear and functional advice to ensure planning and issue resolution.
• Defines regulatory requirements, develops and subsequently implements, plans in support of regional and local business initiatives.

The ideal candidate will come from a strong clinical trial background within Regulatory. Experience of EU scientific advise, PIPs, Orphan drugs and several therapeutic areas is a MASSIVE bonus.

The successful candidate will have fantastic experience and strong verbal and written communication skills. Are you someone that would want to make the step up in your career, then join the queue and apply now.

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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

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