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Regulatory Affairs Manager - EU Lifecycle Maintenance

  • Location

    Berkshire, England

  • Sector:

    Regulatory Affairs

  • Job type:

    Permanent

  • Salary:

    Negotiable

  • Contact:

    Matt Thomas

  • Contact email:

    matt.thomas@pharma-partners.co.uk

  • Job ref:

    21785_1602760665

  • Published:

    13 days ago

  • Consultant:

    Matt Thomas

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