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