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Regulatory Information Management Project Manager

  • Location

    Essex, England

  • Sector:

    Regulatory Affairs

  • Job type:

    Permanent

  • Salary:

    Negotiable

  • Contact:

    Matt Thomas

  • Contact email:

    matt.thomas@pharma-partners.co.uk

  • Job ref:

    25623_1633601662

  • Published:

    10 days ago

  • Consultant:

    Matt Thomas

Job title: Regulatory Information Management Project Manager

A global pharmaceutical business in Essex are seeking a Regulatory Project Manager. This role will focus on Regulatory Information Management in the Global Regulatory Operations team.

Responsibilities:

  • Develop and implement the RA business systems strategy required to ensure that Global Regulatory Affairs (GRA) systems continue to meet ongoing and emerging business needs.
  • Provide the expert business analysis input required for the successful development of strategic system roadmaps and for the successful implementation of the projects required to ensure the delivery of the technology solutions required to support the GRA business and its partner functions.
  • Manage and deliver XEVMPD submissions operation to ensure Article 57 compliance.

Requirements:

  • Bachelor's Degree in Life Sciences or Information Technology (required)
  • Demonstrable experience of the Pharmaceutical industry with direct experience in Regulatory Affairs
  • Knowledge of global (FDA, EMA, Health Canada and Japan) regulatory requirements.
  • Experience with Parexel (Calyx)/Liquent's Insight regulatory information management suite of products (desired)
  • Knowledge of industry regulatory standards (eCTD, CDISC, EVPRM, SPL, ISO IDMP etc).

Salary and benefits:

A highly competitive salary, annual bonus, private healthcare and wider benefits package is on offer.

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