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Sinead Cullen
Life Science

01 507 9252
[email protected]
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Details

Regulatory Affairs Technical Manager remote working


Reference:SCAQNW-870838 Location: Kerry
Qualification:DegreeExperience:4-5 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Regulatory Affairs, Regulatory Affairs Executive, Regulatory Affairs Manager, Regulatory Affairs Officer, Regulatory Affairs Specialist

Regulatory Affairs Technical Manager 100% remote working
Our client, an animal health organisation, are currently recruiting for a Regulatory Affairs Technical Manager to join their team. This is a super opportunity for an experienced Regulatory professional from an animal health or pharmaceutical background to work 100% remotely.

Responsibilities

  • Responsible for preparation of the Part 1 and CMC/Part 2 files for dossiers for Marketing authorisations
  • Create and oversee studies needed, including technical/scientific input for pharmaceutical studies needed for sections of dossier preparation
  • Support product life cycle regulatory issues including post marketing authorisation changes/variations, amendments, renewals, including all associated technical pharmaceutical studies, Pharmacovigilance
  • In conjunction with the quality team, provide technical and regulatory input to quality & QA for documentation associated with existing product manufacture
    • Raw material and packaging specifications
    • Manufacturing processes
    • Process validation data
    • QC procedures
    • Analytical methods and Method validation Studies
    • Stability Studies
    • Technical agreements with CMO's
    • Production records
  • Liaise as needed with CMO's, API suppliers, CRO’s providing technical and quality inputs on regulatory matters, including studies for new licences or variations, change controls, regulatory filing matters and audits for regulatory compliance
  • Other duties relating to pharmaceutical aspects of the products that may arise
  • Member of the project team for new product development
Requirements
  • Degree in Chemistry or related discipline
  • 3-5 years industry experience
  • Experience working in reg affairs or pharmacovigilance

For more information please contact Sinéad Cullen on siné[email protected] or +353879500821