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Vacancy details
Vacancy description:
Job Code:
J779709
Job Title:
Regulatory Affairs Associate
Job Category:
Regulatory And Drug Safety
Contract:
Locum/Temporary
Discipline:
Regulatory Affairs
Country:
United Kingdom
Location:
Berkshire, Hampshire, London - Central, Surrey, West Sussex, London - East, London - South, London - West
Min experience:
N/A
Annual salary:
Negotiable
Apply by:
16 May 2008
A TOP biotechnology company based in Surrey, are looking to recruit a Regulatory Affairs Associate within GCP. If you have 2-5 years of relevant pharmaceutical industry experience within either regulatory compliance or direct quality assurance experience then this should be your next career move!
Purpose:
This individual will assist in all aspects of clinical compliance and QA activities, including documentation review, internal process audits and external site and vendor audits and follow-up, providing guidance to clinical operations, ensuring appropriate systems and procedures are in place to comply with applicable regulations and guidelines, company SOPs, and study requirements. Additionally they will assist with submission of regulatory documents and with correspondence with Agencies. .
Major Responsibilities:
- Assist in regulatory submissions and correspondence within the EU and RoW
In Conjunction with RTP office:
- Assist in implementing and maintaining a comprehensive GCP compliant quality program.
- Plan and conduct external site and vendor audits according to company SOPs.
- Assist in preparing audit responses and evaluating adequacy of corrective actions.
- Assist in identifying and developing standard operating procedures (SOPs) and systems needed to comply with regulatory requirements.
- Plan and conduct internal clinical process audits according to company SOPs.
- Perform quality reviews of protocols, case report forms and other supplemental study documentation.
- Perform database quality assurance audits prior to database release.
- Perform quality audits of data tables and study reports.
- Perform document record review including, general study files, site specific study files, both clinical and pharmacological, etc.
- Provide summary reports to management of audit activities.
- Assist in the coordination and conduct of clinical training programs.
- Assist in the development of departmental training programs.
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