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Global Regulatory Affairs Associate Director

Global Regulatory Affairs Associate Director

  • Location

    Oxfordshire, England

  • Sector:

    Regulatory Affairs

  • Job type:

    Permanent

  • Salary:

    Negotiable

  • Contact:

    Matt Thomas

  • Contact email:

    matt.thomas@pharma-partners.co.uk

  • Job ref:

    20355_1583856285

  • Published:

    7 months ago

  • Expiry date:

    2020-04-09

  • Consultant:

    #

Job title: Regulatory Affairs Associate Director, Neurology Phase II - EU Lead

A biopharmaceutical company based in Oxfordshire are seeking an Associate Director to work on an exciting Neurology product - currently in Phase II. This role will act as the EU Lead and will take responsibility for EMA and CHMP meetings.

Responsibilities:

  • Act as EU/ROW regulatory affairs representative on project teams by providing direction and solutions
  • Develop and implement EU/ROW regulatory strategies to facilitate the progress of programmes in all phases of development
  • Ensure the timely submission of briefing books for regulatory meetings, CTAs MAAs and Variations
  • Act as the lead for upcoming EMA and CHMP meetings

Requirements:

  • Broad knowledge of EU/ROW Regulatory affairs with direct experience within submissions and approvals
  • Proven track record of effective collaboration with regulatory agencies such as the EMA and CHMP
  • Minimum of 8 years regulatory affairs experience across the EU/ROW markets

Salary and benefits:

A competitive salary, car allowance, bonus and long-term incentives are on offer.

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