Job title: Head of Regulatory Affairs

An opportunity has arisen for an established leader within Regulatory Affairs to join a pharmaceutical business in Hertfordshire. This role will have responsibility for mainly post approval activities within the UK and Ireland markets.

Responsibilities:

• Life cycle management activities for existing marketing authorisations (National & MRP/DCP) in the UK and Ireland.
• Assist in compiling (Module 1 Documents) for new marketing authorisation applications for both the UK and Ireland.
• Maintain awareness of existing and new legislation/ guidance and ensuring that colleagues and the business are aware of any changes and potential impacts
• Prepare, submit and follow up applications for export certificates to the MHRA and/or HPRA.

Requirements:

• At least 5 years' experience of regulatory (post approval/post marketing/life cycle management) within the pharmaceutical industry
• Extensive experience within the UK and Ireland markets
• Degree level education in a Life Science discipline
• Scientifically competent with an ability to analyse and assimilate technical data

Salary and benefits:

A highly competitive salary, annual bonus, car allowance and private healthcare are on offer

To apply for this position or hear further details then please contact Matt Thomas via matt.thomas@pharma-partners.co.uk