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Regulatory Affairs Manager

Regulatory Affairs Manager

  • Location

    Slough, Berkshire

  • Sector:

    Regulatory Affairs

  • Job type:

    Permanent

  • Salary:

    Negotiable

  • Contact:

    Matt Thomas

  • Contact email:

    matt.thomas@pharma-partners.co.uk

  • Job ref:

    20833_1591611557

  • Published:

    4 months ago

  • Expiry date:

    2020-07-08

  • Consultant:

    #

Job title: Regulatory Affairs Manager

A growing business focused on the supply of comparator products, is seeking an experienced Regulatory Affairs professional to join as a Regulatory Affairs Manager. In this role, you will be responsible for conducting all associated regulatory activities on a global scale. Candidates must have an understanding of early access programmes.

Responsibilities:

  • Utilise regulatory expertise to develop and deliver optimal regulatory strategies and plans to support the achievement of country business goals for unlicensed supply globally of products on behalf of clients
  • Ensure teams understand the potential opportunities and constraints that the latest legislation/upcoming changes to legislation might create for their commercial activities
  • Develop and enact appropriate strategies in order to negotiate optimal outcomes for the business and patient on product issues
  • Obtain Authority Approvals for Supply of Unlicensed Medicines (Named Patient/Compassionate Use)

Requirements:

  • Life sciences or chemistry graduate to honours level or equivalent
  • Member of The Organisation for Professionals in Regulatory Affairs (TOPRA) preferred
  • Extensive UK and EU experience within Regulatory Affairs
  • Knowledge of the global unlicensed medicines market and or the Pharmaceutical industry is preferred

Salary and benefits:

A competitive annual salary, annual bonus and pension scheme is on offer

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