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Vacancy details
Vacancy description:
Job Code:
J093851
Job Title:
Regulatory Affairs Manager
Job Category:
Regulatory And Drug Safety
Contract:
Permanent
Discipline:
Regulatory Affairs
Country:
United Kingdom
Location:
London - Central, London - North, London - East, London - South, London - West
Min experience:
N/A
Annual salary:
Negotiable
Apply by:
11 Dec 2008
A fantastic opportunity to join a Top independent oganisation as a Regulatory Affairs Manager. This company offers applicants unique opportunities to be involved and take their own approach to processes and systems so independent and ambitious candidates will be well suited. The client is almost entirely funded by the public with income from fundraising, investments and charitable activities. They are a large, complex and dynamic company.
Purpose of the Role -
- To prepare, review and submit optimal CTA applications for designated Drug Development Office projects.
- To ensure CTAs for designated projects are maintained in compliance with the current Clinical Trial Legislation.
- To provide the DDO with regulatory advice on clinical trial activities as required
- To maintain good relations with the MHRA assessors and information processing Unit of the MHRA
- To provide regulatory advice to the Drug Development Team.
- To continue with the continuous review and improvement of systems and processes in the regulatory team, to ensure regulatory compliance and best practice.
Qualifications and Experience Required
- Degree in Scientific discipline
- An understanding of all aspects of drug development (pre clinical) and the data generated to enable the role holder to be able to prepare and review summaries of the pharmaceutical , non clinical and clinical section of the IMP dossier.
- A good understanding of the current requirements of the Clinical Trial Authorisation, MREC and GTAC submissions and other trial application processes.
- Extensive experience in the pharmaceutical industry in pre clinical/clinical drug development and Regulatory affairs.
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