Description
This is a exciting new position as an interim regulatory affairs director for a global bio-pharmaceutical company based in the South-East. Initially the contract is for a period of 6-12 months with a possibility of being extended.The Role:
- Accountable for the development and implementation, at a regional or global level, of the regulatory strategy for a product/ group of products
- Ensuring that the strategy is designed to deliver a rapid approval with advantageous labelling
- Lead the planning and construction of the global dossier and core prescribing information (GRL)
- Conduct regulatory risk planning and mitigation.
- Accountable for the delivery of regulatory milestones including assessment of the probability of regulatory success together with risk mitigation measures.
Key Skills:
- Previous experience in attending and/or helping a team prepare for a Major Health Authority interactions
- >5 years experience or equivalent of regulatory drug development including product approval/launch.
- Expert knowledge of regulatory affairs within one or more therapeutic areas.
- Broad background of experience working in pharmaceutical business and prior experience in several areas within regulatory affairs, e.g. Global, European, International, Marketing Company or experience at a health authority.
- Proven leadership and program management experience.
- Ability to think strategically and critically evaluate risks to regulatory activities.
The hourly rate it between £80-£100 (potentially negotiable) depending on experience.
This is an excellent opportunity to join a fast moving global organisation offering competitive hourly rates. If this is of interest to you or anyone you know, please get in touch as we provide £200 referral vouchers for all placed candidates.
To find out more about Real please visit www.realstaffing.com
Real Staffing, a trading division of SThree Partnership LLP | Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales