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Interim Regulatory Professional

20 November 2017

Our client, a privately-owned speciality pharma and contract manufacturing group, focused on the development and commercialisation of niche high value pharmaceuticals is recruiting for a Regulatory Manager for an initial period of 6 months.

You would become one of the leaders within their hard-working team, managing and overseeing the regulatory duties.  Ideal for an experienced Interim Regulatory Manager.

Role Purpose:
  • Manage requests for proposals and set out scope of work
  • Lifecycle management of small molecule products across the EU
  • Current dossier compliance maintenance
  • Technical agreements, SOPs
  • Oversight of labelling maintenance – labelling impact assessments where PV feeds in
  • NICE and eCTD (electronic common technical document) composition
  • Help QPPV team members identify escalation and risk factors
  • Quality Management Systems
  • Out licencing agreements
  • Help activity surrounding CMC
  • GMP, GDP
  • Budget management


Requirements include:
  • Good knowledge of CMC and risk factors associated PV
  • Good knowledge of labelling obligations
  • Experience of the submission process from an electronic point of view
  • Experience of working with Manufacturing sites
  • Experience of managing virtual teams
  • Experience of dealing with Health Authorities and managing complex issues
  • Experience of supporting the regulatory aspect of clinical trials
  • Range of therapeutic and molecule experience
 
Location: Virtual with a day a week in Dublin
Duration and days per week: 6-12 months, 3-4 days per week
 
To register your interest in this opportunity please forward an up-to-date CV to resourcing@pir-resourcing.com or contact PiR on 01480 499580, quoting reference 882468 and advising current availability and anticipated day rate.