Regulatory Affairs Lead
This is a 6 month contract within a large Pharmaceutical organisation.
- Manage the review, preparation, submission and follow-up of regulatory submissions to the UK and / or Irish regulatory authorities, to high standards, to ensure that marketing authorisations are obtained and maintained in line with the company's plans and goals.
- Oversee regulatory strategy for new marketing authorisation and continued ongoing maintenance activities. Manage the regulatory support for the launch of new products and lifecycle management of the existing portfolio.
- Manage the review, preparation, distribution and follow up of registration documentation required in the EU (particularly UK and Ireland).
Ideal candidate will have:
- Proven success in achieving regulatory approvals in the UK and /or Ireland (recent UK and IRE experience is essential)
- Significant post-licencing experience with an in-depth working knowledge of lifecycle maintenance for pharmaceutical products, including variations and renewals
- Strong leadership capabilities with a record of proven success in managing and supervising staff.
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Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Business in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales