Global Patient Safety Standards & Training Lead

Regeneron Pharmaceuticals, Inc; Uxbridge; Sur place; GBP 90 000 - 125 000; Plein temps

Résumé du poste

Regeneron Pharmaceuticals, Inc. in Uxbridge, UK is seeking an Associate Director to join GPS Standards & Training. You will establish and maintain PV procedures in line with global regulations and company standards, collaborating with P&P, LCoE, and PONs to ensure training reflects current requirements.

This role requires a Bachelor's degree and 7+ years in PV/Drug Safety or related fields. You will lead updates, manage CAPAs, and support audits and inspections, with 3 days on site in the

Qualifications

• Bachelor's degree in life sciences required.
• 7+ years PV/Drug Safety, Regulatory Affairs or QA experience.
• Strong understanding of PV regulations and PV Quality Management Systems.
• Experience managing procedural updates.
• PV process design and optimization experience.
• Ability to write procedural documents to quality standards.
• Experience with audits and inspections.
• Ability to work across functions with SMEs and process owners.

Responsabilités

• Ensure PV updates are reflected in GPS procedures, keeping audit-ready state.
• Collaborate with P&P and Learning Centre of Excellence to align training curriculum with procedures.
• Validate procedures against safety practices and regulations as SME.
• Develop and maintain GPS procedures in line with Regeneron standards and industry best practices.
• Prioritize and sequence procedural updates with PONs and GPS Leads.
• Support CAPA management and training for GPS procedures.
• Represent GPS in audits and inspections.

Connaissances

Pharmacovigilance

Regulatory affairs

Quality assurance

Process design

Project management

Formation

Bachelor's degree in life sciences

Description du poste

Regeneron Pharmaceuticals, Inc. in Uxbridge, UK is seeking an Associate Director to join GPS Standards & Training. You will establish and maintain PV procedures in line with global regulations and company standards, collaborating with P&P, LCoE, and PONs to ensure training reflects current requirements.

This role requires a Bachelor's degree and 7+ years in PV/Drug Safety or related fields. You will lead updates, manage CAPAs, and support audits and inspections, with 3 days on site in the