Company: Regulatory Professionals
Closing Date: 12 May 17
Type: Full Time
Salary (£): On Application
Regulatory Affairs Senior Manager Location: Hertfordshire Salary: Flexible dependant on candidate Employment type: Permanent Do you want to work in a high profile position with autonomy over your work?
Regulatory Affairs Senior Manager
Salary: Flexible dependant on candidate
Employment type: Permanent
Do you want to work in a high profile position with autonomy over your work?
Do you want to work in a strategic position with high responsibility?
A top 20 pharmaceutical company based in Hertfordshire is currently looking for a Senior Regulatory Affairs Manager as a result of expansion. The successful candidate will be leading the preparation of submission documents, you will be accountable for the quality of submissions and be responsible for responding to the Health authorities.
Main Job Responsibilities:
Plan, prepare and complete the CMC section of major submissions
Provide oversight for all CMC aspects on Regulatory submissions
Leads effective responses to Health Agency CMC questions
Regulatory strategy and manages timelines to meet project needs
*Minimum 7 years relevant regulatory experience
*Previous contact with the MHRA/EMA
*Extensive CMC experience
*College or University degree in an associated functional discipline
*Previous experience working with the CMC components for all Regulatory submissions (IND/CTA, NDA/MAA etc.)
Remember if this role is not suitable for you or you are no longer looking for a new job please feel free to forward this to anyone you feel would be suitable. If we successfully find a role for your recommendation we will give you £250 in vouchers of your choice.
Key words: Post approval, Berkshire, Buckinghamshire, Hampshire, Middlesex, London, Hertfordshire, Uxbridge, East Anglia, Essex, Global Markets, Lifecycle, Submissions, CMC, emerging markets, pharmaceutical, Regulatory, Affairs, Manager, Senior Manager, Project management, CTA, Drug development
3rd floor 33 Blagrave Street Reading
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