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.
- 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
- 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 firstname.lastname@example.org