Company: Regulatory Professionals
Closing Date: 20 Nov 16
Type: Full Time
Salary (£): On Application
Regulatory Affairs Associate Director \ Regulatory Affairs Director: Hertfordshire - Maybe a couple of day's home working for the right candidate. Salary: Up to £80,000 - £95,000 per annum. Regulatory Professionals are working with an exciting CRO with a fantastic team
Regulatory Affairs Associate Director \ Regulatory Affairs Director
Location: Hertfordshire - Maybe a couple of day's home working for the right candidate
Salary: Up to £80,000 - £95,000 per annum
Employment type: Permanent
Regulatory Professionals are working with an exciting CRO with a fantastic team and culture. The company focuses primarily on Advance Therapies and due to their recent success, they are looking for a Regulatory Affairs Associate Director or Director.
Main Job Responsibilities:
*Advice on EU/US Strategy
*Scientific advice, Innovation Task Force, Protocol assistance, Orphan submissions
*Product development strategy
*Advanced therapy medicinal products (ATMP)
*Early access to medicines (compassionate use programs, Named Patient Programmes)
*Health technology assessments
*Good Manufacturing Practice
*Relevant Regulatory experience at this level
*Orphan drug experience / ATMP essential
*Led and attended Scientific Advice meetings
*Understanding of the EU Regulatory environment
*Strong Early phase experience
*Experience with PIPs
*Experience of having input into clinical development plans
*Must have strategic regulatory experience
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: 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, Strategy, MAA, MAAs
3rd floor 33 Blagrave Street Reading
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