Reg Affairs Manager: Vaccines (12 months)
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- Worthing
- Posted 25th Feb 2010
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Posted by:
SLS Services Limited
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Salary:
Up to £ 50,000
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Job Type:
Permanent
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Address:
2nd Floor, 7-8 Sterling Buildings
The Carfax
Horsham
RH12 1DR
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Contact:
01403 216 216
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Reference:
9831 ST
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Job Description
Job Details
€¢ Interim Regulatory Affairs Manager (initially for 12 months but with a good chance of becoming permanent: see below)
€¢ Based in Worthing, West Sussex
€¢ Strong Reg Affairs experience essential, covering New Product Development, Clinical, Marketing and Manufacturing activities
€¢ Good team leadership skills and experience essential
€¢ Immunology / Biochemistry / Biology background preferred due to complex nature of products
€¢ Salary negotiable depending on experience (up to £50k ish)
Summary
An exciting opportunity for a Senior Reg Affairs professional with excellent leadership skills, to join one of the most innovative companies in the South East. This is initially for a 12-month contract (on the company’s payroll) but there is a good chance it will become permanent once some large European dossier submissions have taken place at 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 they have a healthy clinical pipline.
The Role
Based in a fairly quiet but very busy office, you will take ownership of a small Regulatory team responsible for all areas of Development, Clinical Trials, Manufacturing and Marketing plans. In close liaison with the company’s second office in Germany, you will manage some key ongoing projects and become a central point of contact regarding regulatory (and pharmacovigilance) matters.
This role would be an excellent step for someone with 8+ years’ experience in Reg Affairs and the desire to learn about complex vaccines, to lead a highly competent team and introduce new systems for optimum compliance.
Benefits
Experience
The successful candidate will have a life science background and several years’ experience of working at a senior level within Reg Affairs, ideally within a ‘Big Pharma’ environment (as opposed to a generics / parallel import organisation). You must have an analytical mind and first-rate communication and management skills, being able to work on your own initiative.
Keywords
Reg Affairs Manager, Regulatory Affairs, CTD, eCTD, Drug Safety, Clinical Safety, PSUR, Clinical Trial, Pharmacovigilance, MHRA, FDA, Project Management
SLS Services Ltd operates & advertises as an Employment Agency for permanent positions and as an Employment Business for contract/temporary positions.
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