Shreeya Patel is recruiting an Interim Director of Regulatory Affairs to join a global pharmaceutical company at their site near Uxbridge on a contractual basis.
As Interim Director of Regulatory Affairs you will be working in a small group with other Regulatory experts of similar levels of seniority. The company has an extremely strong pipeline for the size that they are which makes it a very exciting time to join them.
As Interim Director of Regulatory Affairs you will:
- Managing assigned EU regulatory submissions to obtain timely approvals of Clinical Trial Applications
- Lead and manage the preparation (content and format) of all assigned CTA submissions to agencies both national and EMA.
- The Interim Director of Regulatory Affairs will also be liaising, negotiating and communicating within functional groups within the company, corporate partners, affiliates and agencies related to assigned products and projects.
The successful candidate will have demonstrable experience in Regulatory Affairs within the Pharmaceutical Industry with particular emphasis on drug development and managing clinical trial applications phase 1 to 3 (including amendments) and MAAs in EU and non-EU countries.
The successful candidate for the Interim Director of Regulatory Affairs role will have:
- Working knowledge of laws, regulations and guidelines
- Experience working in a global, international regulatory environment and experience interacting with regulatory authorities. Experience within the development and preparation of paediatric investigational plans (PIPs) within cardiovascular would also be preferred
How to apply
For more information or to apply for the role please contact Shreeya Patel on 01438 743047 or email email@example.com. Please quote reference CL26003 in all correspondence. Entitlement to work in the EEA is essential.