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Regulatory Affairs Associate - Steriles - EU Generic

Regulatory Affairs Associate - Steriles - EU Generic

  • Location

    Essex, England

  • Sector:

    Regulatory Affairs

  • Job type:

    Permanent

  • Salary:

    Negotiable

  • Contact:

    Matt Thomas

  • Contact email:

    matt.thomas@pharma-partners.co.uk

  • Job ref:

    24015_1623163461

  • Published:

    4 months ago

  • Expiry date:

    2021-07-08

  • Consultant:

    #

Job title: Regulatory Affairs Associate - Steriles - European Generic Registration

A global pharmaceutical company in Essex are seeking an experienced regulatory affairs individual to join their EU submissions team. This role will focus on Steriles within the European markets.

Responsibilities:

  • Manage new MAAs submitted via Decentralised (DCP), Mutual Recognition (MRP) and Centralised (CP) procedures.
  • Work closely with line manager to coordinate preparation of high-quality dossiers, which fulfil regulatory requirements and Health Authority (HA) expectations.
  • Where requested, review third party dossiers and with line manager identify risks and communicate RA input on approvability to other team members.
  • Keep up to date on regulatory trends in the EU Region.
  • Provide central RA support to EU countries, CA, CH and International Markets.

Requirements

  • Pharmacy/Chemistry or Life Sciences degree.
  • Knowledge of regulatory requirements, process, procedures, & pathways.
  • Experience in Sterile/Complex Generics is essential
  • Prior EU Regulatory experience would be advantageous

Salary and benefits:

A competitive annual salary and benefits scheme is on offer with this role

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