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Vacancy details
Vacancy description:
Job Code:
JW - 2391
Job Title:
Regulatory Associate
Job Category:
Regulatory And Drug Safety
Contract:
Locum/Temporary
Discipline:
Regulatory Affairs
Country:
United Kingdom
Location:
Berkshire, Hampshire, Hertfordshire, Surrey, West Sussex, Middlesex, London - South, London - West
Min experience:
N/A
Annual salary:
Negotiable
Apply by:
31 May 2008
• Top 10 Pharmaceutical company
• 6 month contract
• Experience with Regulatory affairs required
• Office based in Surrey/Berkshire boarders
Job Background
The RS (Resourcing Solutions) department of Chiltern International acts in a similar way to that of a staffing solutions provider. The department is currently seeking a Regulatory Associate to work for our client, a major Pharmaceutical company at their offices in Windlesham in Surrey (near Ascot).
Job Primary Functions
Objective - Support senior scientist on program or Product Team: Maintain licences after approval; Support clinical trial applications and other regulatory submissions in European countries.
•Provide regulatory information on request or indirectly via website update
•Establish and maintain quality files (electronic and /or paper)for quick easy access
•Establish and maintains database and status reports
•Support clinical trial applications in European countries
•Prepare variation and other submissions
•Implement aspects regulatory plan and establish regulatory timetable
•Provide information on new legislation, regulatory guidelines (including electronic submission formatting requirements) and relevant changes in the external environment
Job Qualifications
•Understanding of the cross functional nature of drug development and regulatory implications
•Understanding and knowledge of medicines
•Graduate qualification in a relevant subject
•Relevant work experience
•Use of databases relevant to regulatory business
You must be eligible to work in the UK.
A full job description is available.
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