about 1 year ago
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.
- 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.
- 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 firstname.lastname@example.org