Job title: Regulatory Affairs Manager – Immunology
A global Top 10 Pharma are seeking a Regulatory Affairs Manager. This is a leadership opportunity, line managing Regulatory Affairs Project Manager and Regulatory Affairs Specialist. The role will focus on a growing Immunology portfolio consisting of both established and development assets. The position is office based 3 days per week in Berkshire.
Responsibilities:
- Leading a team of Project Managers and Regulatory Affairs Specialist within the Immunology team, with scope for the UK market
- Delivering the product responsibility for all regulatory activities relating maintaining to licensing, changes to regulations and submissions to MHRA including developing new submissions (Clinical Trial Authorization) and execute the strategy for the group
- Key contributor, as a part of a Brand Team representing Regulatory Affairs
- Could involve reviewing ABPI code including materials assessed, examined or certified by a non-pharma, final signatory
- Lead on continuous and process improvement projects
Requirements:
- University degree in Pharmacy, Pharmacology, Biology or related disciplines
- Experience in regulatory affairs position, strong understanding of the UK market and preferably, experience with line management or coaching
- CTA experience of pre-licensing application, to be able to train and guide direct reports
- Strong communications and coordination skills
- Proficiency in communicating strategic and tactical issues to management.
Salary and benefits:
A highly competitive salary, annual bonus and wider benefits package is on offer
To apply for this position or hear further details then please contact Matt Thomas via matt.thomas@pharma-partners.co.uk
