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Senior Regulatory Affairs Associate - EU New Submissions

  • Location

    Essex, England

  • Sector:

    Regulatory Affairs

  • Job type:

    Permanent

  • Salary:

    Negotiable

  • Contact:

    Matt Thomas

  • Contact email:

    matt.thomas@pharma-partners.co.uk

  • Job ref:

    25622_1633599934

  • Published:

    10 days ago

  • Consultant:

    Matt Thomas

Job title: Senior Regulatory Affairs Associate - EU New Submissions

A global pharmaceutical company in Essex are seeking a Senior Regulatory Affairs Associate. This role will focus on new submissions of generic products in the EU.

Responsibilities:

  • Manage new MAAs submitted via Decentralised (DCP) and Mutual Recognition (MRP).
  • Provide central RA support to EU countries, CH and International markets
  • Coordinate preparation of high-quality dossiers which fulfill regulatory requirements and Health Authority (HA) expectations.
  • Keep up to date on regulatory trends, risks and opportunities in the EU Region.
  • Prepare and manage the post-approval commitments and maintenance work on post-approval variations for authorised products

Requirements:

  • Experience in registration of medicinal products in the EU.
  • Regulatory knowledge throughout product life cycle with substantial experience with various products/devices.
  • Pharmacy/Chemistry or Life Sciences degree.
  • Regulatory strategy development with a focus on bringing innovative solutions to project teams and health authorities.

Salary and benefits:

A highly competitive salary, annual bonus, health insurance and wider benefits package is on offer

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