Senior Manager Regulatory Affairs

A growing speciality pharmaceutical business is expanding its European Regulatory Affairs team with the addition of a new Senior Regulatory Affairs Manager position.

In this role, you will be responsible for portfolio of innovative products, leading end to end submission / lifecycle and play a key role in evaluating in-licensing and acquisition opportunities, acting as the regulatory lead in due diligence activities.

Key Responsibilities

Regulatory Strategy, Submissions & Lifecycle

• Lead EMA Centralised Procedure Marketing Authorisation Applications (MAAs) from submission through approval.
• Manage corresponding MHRA submissions and UK regulatory requirements.
• Prepare and lead responses throughout the assessment process to successful grant.
• Develop regulatory strategies for new assets entering the European portfolio.
• Lead Scientific Advice procedures and Paediatric Investigation Plans (PIPs) with EMA and MHRA.
• Manage lifecycle activities, including variations, commitments, renewals, and orphan products.
• Support and mentor less experienced members of the Regulatory team.

Regulatory Due Diligence & Portfolio Development

• Act as the regulatory representative in cross-functional in-licensing and asset evaluation activities.
• Review Scientific Advice outcomes and assess development obligations and regulatory risks.
• Critically evaluate Modules 1–5 to identify gaps, deficiencies, and approval risks.
• Partner with Clinical, Safety, CMC, Commercial, Market Access, and Quality teams to support investment and go/no-go decisions.

Requirements

• 5–10 years' Regulatory Affairs experience within an innovative pharmaceutical environment
• Hands-on experience leading a Centralised Procedure MAA end-to-end through approval (essential)
• Strong experience with EMA and MHRA submissions and post-Brexit UK regulatory requirements
• Experience managing or leading Scientific Advice procedures with EMA and/or MHRA
• Strong understanding of European regulatory strategy for speciality products (Injectables or inovative formulations)
• Degree in Pharmacy, Life Sciences, or related discipline
• Full right to work in the UK (sponsorship unavailable)

This is a full time permanent role, hybrid working from Slough.

#J-18808-Ljbffr

Full job description from WhatJobs. Apply for this role →