Job title: Regulatory Affairs Manager

A Pharmaceutical business in Berkshire are seeking a Regulatory Affairs Manager. In this role you will maintain marketing applications, develop submission strategies, and gain marketing authorisations for new countries.

Responsibilities:

• Management of MA maintenance activities for National and MRP procedures including submission of variations and renewals
• Liaising with affiliates to ensure submission of MAAs meets local regulatory guidelines
• Preparation of registration dossiers and submissions of MAAs are in line with regulatory requirements
• Act as Regulatory lead for agency interactions, including inspections, responses to agency letters and advisory meetings
• Create and maintain SOPs and Work Instructions for the Regulatory function
• Maintains awareness of global Regulatory legislation and assesses its impact on the business and product development programs

Requirements:

• Proven experience in EU Regulatory Affairs within an established products environment
• Upto date knowledge of applicable EU Regulations, Directives and Guidance
• Experience working with regulatory agencies (MHRA/HPRA and EMA)
• Medical Device experience is desirable but not essential
• Life sciences degree or equivalent

Salary and benefits:

A competitive salary, annual bonus, car allowance and further benefits are on offer.

To apply for this position or hear further details then please contact Matt Thomas via matt.thomas@pharma-partners.co.uk