Global PV Standards & Training Lead

Regeneron Pharmaceuticals

Uxbridge

Hybrid

GBP 90,000 - 140,000

Full time

14 days+

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Job summary

Regeneron Pharmaceuticals in the UK is seeking an Associate Director to join the Global Patient Safety Standards & Training team. You will establish and maintain PV procedures across territories, collaborating with P&P and the LCoE to keep training aligned with evolving regulations and industry best practices.

You will lead GPS process design, oversee CAPAs, and partner with Process Owners and SMEs to ensure readiness for audits and inspections.

Qualifications

  • Bachelor’s degree in life sciences; PV background a strong plus.
  • 7+ years in Pharmacovigilance, Drug Safety, Regulatory Affairs or QA.
  • Strong understanding of PV regulations and PV Quality Management Systems.
  • Experience managing procedural updates and training content.
  • Ability to design and optimize PV processes and training curricula.
  • Track record in project management for documentation and compliance.

Responsibilities

  • Ensure PV procedures align with regulations and update as standards evolve.
  • Coordinate with P&P and LCoE to reflect procedural changes in training.
  • Validate procedures with GPS Safety Ops and map docs to regulations.
  • Develop and maintain GPS procedures in partnership with P&P and SMEs.
  • Prioritize procedural updates with PONs and GPS Functional Leads.
  • Support CAPA closure and ensure training adequacy for updates.
  • Provide metrics on CAPAs, deviations, and training compliance.

Skills

Pharmacovigilance
Regulatory Affairs
Quality Assurance
PV System design
Training curriculum
CAPA management
Cross-functional collaboration

Education

Bachelor’s degree in life sciences

Job description

Regeneron Pharmaceuticals in the UK is seeking an Associate Director to join the Global Patient Safety Standards & Training team. You will establish and maintain PV procedures across territories, collaborating with P&P and the LCoE to keep training aligned with evolving regulations and industry best practices.

You will lead GPS process design, oversee CAPAs, and partner with Process Owners and SMEs to ensure readiness for audits and inspections.

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