Description
Regulatory Affairs Specialist: Global Pharmaceutical CompanyLocation: Cambridge with potential for some home working
Salary: £40,000 - £45,000 + excellent package
________________________________________________________________________
KEY RESPONSIBILITIES
- Management and support of Clinical Trial Applications
- Building and maintaining relationships with other functions within the company
- Maintaining and development of Regulatory Systems and administrative activities
- Maintaining cGxP and H&S knowledge applicable to the job
- Other duties as required
Management of Clinical Trial Applications
- Provide regulatory advice to other stakeholders involved in clinical trials
- Liaise with Health Authorities or local contacts in regard to CTA submissions
- Coordinate, compile and submit clinical trial applications (CTAs) as agreed with the Clinical Department ensuring appropriate internal processes are followed
- Ensure all CTAs are made within the agreed timeframes
- Provides oversight of appointed CRO/CRA to ensure appropriate processes are adhered to
- Liaise with all the necessary personnel to keep them informed of progress, actions and activities, as necessary
Education/Qualifications Required:
Graduate, postgraduate or equivalent, ideally in a scientific or healthcare discipline.
If you are interested in finding out more information please send your updated C.V to Natalie Hopkins at n.hopkins(a)realstaffing.com or call for more opportunities