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Regulatory Affairs Project Manager - Homebased

  • Location

    Buckinghamshire, England

  • Sector:

    Regulatory Affairs

  • Job type:

    Permanent

  • Salary:

    Negotiable

  • Contact:

    Matt Thomas

  • Contact email:

    matt.thomas@pharma-partners.co.uk

  • Job ref:

    24972_1636447181

  • Published:

    27 days ago

  • Consultant:

    Matt Thomas

Job title: Regulatory Affairs Project Manager - Home Based

A research-oriented pharmaceutical company in Buckinghamshire are seeking a Regulatory Affairs Manager to work across the UK and EU markets. This role will mainly focus on maintenance of marketed products but will also have coverage to work within development assets.

Responsibilities:

  • Act as key regulatory contact for interactions with the local authorities on all regulatory matters
  • Submit, maintain and manage regulatory applications/periodic reports and renewals ensuring regulatory compliance
  • Input and prepare relevant sections of Marketing Authorisation, variations and clinical trial application dossiers to gain regulatory authority approvals
  • Provide scientific and technical support, and ensuring the information exchange of regulatory affairs matters, to internal and external stakeholders

Requirements:

  • Minimum of 5 years' experience within Regulatory Affairs (Ideally Pharma)
  • Experience within UK/IE and EU markets is essential
  • Full life cycle experience is essential
  • Ability to work with various cross functional teams and departments

Salary and benefits:

A highly competitive salary, annual bonus and private healthcare are on offer

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