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Regulatory Affairs Project Manager

  • Location

    Berkshire, England

  • Sector:

    Regulatory Affairs

  • Job type:

    Permanent

  • Salary:

    Negotiable

  • Contact:

    Freddie Hill

  • Contact email:

    freddie.hill@pharma-partners.net

  • Job ref:

    21743_1602520090

  • Published:

    16 days ago

  • Consultant:

    Freddie Hill

Job title: Regulatory Affairs Project manager - Neuroscience

A global biopharmaceutical company in Berkshire are looking for a Regulatory Affairs Project manager to work within their Neuroscience portfolio. This role will be responsible for the post approval life cycle management of two products. The ideal candidate will have experience in the maintenance of complex products as well as significant experience in regulatory affairs.

Responsibilities:

  • The development, flawless execution and implementation of regulatory strategies and activities for both products.
  • Provide regulatory input into the Integrated Development Plan. In collaboration with other Research & Development departments, define the optimal plan to reach the target product profile.
  • Continuously evaluate the match between development objectives and current plan versus new key findings and regulatory requirements.
  • Accountable for the flawless execution and implementation of the related Global Regulatory plans and activities with internal or external resources as appropriate

Requirements:

  • Substantial experience within Regulatory affairs and Pharmaceutical industry
  • Significant post approval experience working with multiple products/projects
  • Solid project management skills. Able to develop and implement short to mid-term plans or delivery of small to medium scale projects.
  • Experience across UK and EU markets would be beneficial

Salary and benefits:

A highly competitive salary and wider benefits scheme is on offer

To apply for this position or hear further details then please contact Freddie Hill via freddie.hill@pharma-partners.co.uk