Job title: Regulatory Affairs Manager (UK/IE)

A Pharmaceutical company in Berkshire are seeking a Regulatory Affairs Manager to join their team. This role will be responsible for maintaining marketing authorisation for the company's existing products as well as providing strategic regulatory input.

Responsibilities:

• Input into the preparation of applications to the MHRA/HPRA for Clinical Trial and Marketing Authorisation approval.
• the preparation of registration files and submission of MAAs in line with Regulatory
• Act as point of contact for Regulatory agency interactions including the preparation of briefing packages and strategy for meetings.
• Create and maintain SOPs and Work Instructions for the Regulatory

Requirements:

• Substantial experience within Regulatory affairs and Pharmaceutical industry.
• Significant post approval experience working with multiple products/projects.
• Proven experience in UK/IE Regulatory Affairs within either a R&D or established products
• Previous experience working with MHRA/HPRA would be beneficial.

Salary and benefits:

A highly competitive salary and wider benefits scheme is on offer.

To apply for this position or hear further details then please contact Freddie Hill via Freddie.hill@pharma-partners.co.uk