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Regulatory Submissions Advisor

  • Location

    London, England

  • Sector:

    Regulatory Affairs

  • Job type:

    Permanent

  • Salary:

    Negotiable

  • Contact:

    Matt Thomas

  • Contact email:

    matt.thomas@pharma-partners.co.uk

  • Job ref:

    22981_1630503165

  • Published:

    21 days ago

  • Consultant:

    Matt Thomas

Job title: Regulatory Submissions Advisor

A global Clinical Research Organisations with offices in Central London are looking to expand their Regulatory Submissions team. This role will provide regulatory submissions strategic advice and guidance to the Regulatory Submissions Manager (RSM), internal project team, and Sponsor to facilitate submissions compliance with appropriate regulations and requirements.

Responsibilities:

  • Prepare and/or review core trial documents for compliance with relevant guidelines/regulations and for trial suitability
  • Review pertinent regulations and guidance to develop proactive solutions to regulatory issues and challenges
  • Present during bid defenses, general capabilities meetings, and audits, as required
  • Independently interact with Sponsors, regulatory agencies and internal colleagues

Requirements:

  • Bachelors/Master's/PhD degree within Life Sciences
  • Comprehensive understanding of regulatory documentation, guidelines and legislation
  • Demonstrated ability to independently review and interpret regulatory guidance and develop proactive solutions to regulatory issues and challenges

Salary and benefits:

A competitive annual salary and benefits package is on offer with this role.

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