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(Senior) Regulatory Affairs Manager - EU Development

(Senior) Regulatory Affairs Manager - EU Development

  • Location

    London, England

  • Sector:

    Regulatory Affairs

  • Job type:

    Permanent

  • Salary:

    Negotiable

  • Contact:

    Matt Thomas

  • Contact email:

    matt.thomas@pharma-partners.co.uk

  • Job ref:

    22275_1607013934

  • Published:

    11 months ago

  • Expiry date:

    2021-01-02

  • Consultant:

    #

Job title: (Senior) Regulatory Affairs Manager - EU Development Focus

A global clinical research organisation with offices in Central London are looking to expand their regulatory team. These roles will provide full-service support for development phase products across a range of therapy areas.

Responsibilities:

  • Maintaining full regulatory applications including Paediatric Investigation Plans (PIPs), Orphan Designations and Market Authorisation Applications (MAAs)
  • Develop and review of regulatory submission documents for Interaction with EMA, MHRA, and other regulatory agencies
  • Developing scientific and regulatory documents for EU agency meetings.
  • Providing regulatory advice and guidance to Sponsors and other cross functional departments to ensure compliance with UK and European regulations and requirements

Requirements:

  • Experience with EMA, MHRA and other EU regulatory agencies is preferred
  • Experience within Paediatric Investigation Plans (PIPs), Orphan Designations, and Market Authorisation Applications (MAAs) is essential
  • Bachelor's degree as a minimum.
  • Experience at all stages within the product life cycle.

Salary and benefits:

  • Private Medical and Dental insurance
  • Company matched pension
  • Performance related bonus
  • Competitive base salary

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