Senior Regulatory Executive – CMC

We are working with a global pharmaceutical client currently looking for a senior regulatory executive to prepare CMC submissions for biopharmaceuticals. The main scope of the role is the preparation of high-quality CMC regulatory documents for new Biopharmaceutical products, using varied information sources and liaising closely with other personnel to ensure accuracy of such records.

The successful candidate will have experience in the following areas:

• CMC Regulatory Affairs experience; planning, authoring, reviewing and project management of regulatory submissions.
• Good written and oral communication.
• Demonstrated ability to focus, work with attention to detail and retain critical information.
• Demonstrated team working skills, with the ability to establish strong relationships and liaise effectively with other sites worldwide. Demonstrated effective time management skills.

As well as this, candidates will ideally have global experience (including EU, US, Japan, China and emerging markets) in the following types of CMC submissions:

• Biopharmaceutical experience gained with direct involvement in regulatory submission preparation.
  • Marketing applications for new medicines and managing the related responses to questions.
  • Post approval variations.

This is initially a 12-month contract position, with potential to get extended, and is initially remote but will require some time on site in Brentford. If this sounds like the role for you, apply with your CV now and feel free to contact Tom Kirkpatrick for more information.