Regulatory Affairs Lead

Location: Reading, England, United Kingdom
Salary: No information
Job Type: Contract
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This is a 6 month contract within a large Pharmaceutical organisation.

Duties:

  • 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.

Please click here to find out more about our Key Information Documents. Please note that the documents provided contain generic information. If we are successful in finding you an assignment, you will receive a Key Information Document which will be specific to the vendor set-up you have chosen and your placement.

To find out more about Real please visit www.realstaffing.com

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

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