Global PV Standards & Training Director

Regeneron Pharmaceuticals, Inc.; Uxbridge; Hybrid; GBP 90,000 - 125,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. in the UK seeks an Associate Director to join the Global Patient Safety Standards & Training team in Uxbridge.

You will establish and maintain procedures that meet pharmacovigilance regulatory requirements and industry standards. Reporting to the Head of GPS Standards & Training, you will partner with P&P, LCoE, and SMEs to ensure procedures align with regulations and drive training curriculum updates.

Qualifications

• Minimum Bachelor's degree is required. Education in the life sciences is a strong plus.
• 7+ years' experience of Pharmacovigilance/Drug Safety, Regulatory Affairs or Quality Assurance in the pharmaceutical/biotech industry.
• Thorough understanding of Pharmacovigilance/Drug Safety regulations and PV Quality Management Systems.
• Extensive experience managing procedural updates.
• Experience in PV process design and optimization.
• Track record of successful project management relevant to document management.
• Strong organizational skills.

Responsibilities

• Ensure PV procedures remain aligned with current regulatory expectations and audit readiness.
• Act as liaison to P&P and LCoE for procedural updates and training curricula.
• Validate procedures with GPS Safety Operations; map to regulations and training.
• Develop, implement, and maintain GPS procedures in line with Regeneron Standards and industry best practices.
• Lead assessment of evolving global PV regulations with P&P, PONs and SMEs.
• Set risk-based prioritization for procedural updates across the GPS framework.
• Coordinate with P&P to align PPD expiration dates with procedure projects.
• Represent GPS in audits and inspections and address non-compliance issues.
• Manage GPS procedures content with Process Owners; track CAPA closure and training needs.
• Provide regular metrics on CAPAs, deviations, and training compliance.

Skills

Pharmacovigilance

Regulatory Affairs

Quality Assurance

PV process design

Project management

Documentation

Audits & inspections

Cross-functional collaboration

Data Privacy

Education

Bachelor's degree in life sciences

Job description

Regeneron Pharmaceuticals, Inc. in the UK seeks an Associate Director to join the Global Patient Safety Standards & Training team in Uxbridge.

You will establish and maintain procedures that meet pharmacovigilance regulatory requirements and industry standards. Reporting to the Head of GPS Standards & Training, you will partner with P&P, LCoE, and SMEs to ensure procedures align with regulations and drive training curriculum updates.