Global Patient Safety Standards & Training: Associate Director

Regeneron Pharmaceuticals; Cambridge; On-site; GBP 118,000 - 192,000; Full time

Job summary

Regeneron Pharmaceuticals is seeking an Associate Director to join the Global Patient Safety Standards & Training team. You will establish and maintain PV procedures aligned with global regulations, collaborate with P&P and LCoE, and ensure training curricula reflect updated procedures.

The role requires 7+ years in Pharmacovigilance/Drug Safety, strong PV process design knowledge, and proven project management in document control.

Qualifications

• Bachelor’s degree in life sciences required.
• 7+ years in Pharmacovigilance/Drug Safety or related field.
• Thorough understanding of PV regulations and PV Quality Management Systems.
• Extensive experience managing procedural updates.
• Experience in PV process design and optimization.
• Track record in project management of document management.
• Ability to write procedural documents to quality standards.
• Experience presenting in audits and inspections.
• Ability to collaborate across functions with SMEs and Process Owners.

Responsibilities

• Ensure PV intelligence updates align with GPS procedures and training curriculum.
• Liaise with P&P and Learning Centre of Excellence to update procedures.
• Validate procedures against safety practices and regulations.
• Develop and maintain GPS procedures per regulations and industry best practices.
• Prioritize and sequence procedural updates with PONs and GPS leads.
• Support training curriculum alignment with procedural documents.
• Oversee CAPAs tied to GPS procedures and audits/inspections.
• Provide regular metrics on CAPAs, deviations, and training compliance.
• Lead initiatives to improve GPS process effectiveness and efficiency.

Skills

PV/Drug Safety

Regulatory Affairs

Quality Assurance

Project Management

Procedural Updates

PV Process Design

Audits & Inspections

Cross-functional Collaboration

Education

Bachelor’s degree in life sciences

Job description

Regeneron Pharmaceuticals is seeking an Associate Director to join the Global Patient Safety Standards & Training team. You will establish and maintain PV procedures aligned with global regulations, collaborate with P&P and LCoE, and ensure training curricula reflect updated procedures.

The role requires 7+ years in Pharmacovigilance/Drug Safety, strong PV process design knowledge, and proven project management in document control.