Global PV Standards & Training Architect

BioSpace; New Jersey; On-site; USD 157,000 - 257,000; Full time

Job summary

Regeneron is seeking an Associate Director to lead Global Patient Safety Standards & Training. You will establish and maintain PV procedures aligned with regulatory requirements, partner with P&P, LCoE, and SMEs, and ensure readiness for audits.

This role focuses on driving procedural excellence and training integration across GPS functions. You will oversee updates, CAPAs, and training alignment while collaborating with senior leadership to improve process effectiveness in a fast-growing

Qualifications

• 7+ years' experience in Pharmacovigilance/Drug Safety, Regulatory Affairs or Quality Assurance.
• Thorough understanding of PV regulations and PV quality systems.
• Experience managing procedural updates and process design.
• Ability to write clear procedural documents and present in audits/inspections.

Responsibilities

• Ensure PV procedures align with global regulations and GPS standards.
• Collaborate with P&P and LCoE to update training curricula.
• Validate procedures for fitness for purpose with GPS Safety Operations lead.
• Develop and maintain GPS procedures in line with regulations and industry best practices.
• Lead updates across GPS framework and coordinate with PONs and SMEs.
• Oversee CAPAs and training alignment related to GPS procedures.
• Provide metrics on CAPAs, deviations, and training compliance.
• Represent GPS Standards & Training in audits and inspections.

Skills

PV/Drug Safety experience

Regulatory affairs

Quality assurance

Project management

Procedural writing

Cross-functional collaboration

Education

Bachelor's degree in life sciences

Job description

Regeneron is seeking an Associate Director to lead Global Patient Safety Standards & Training. You will establish and maintain PV procedures aligned with regulatory requirements, partner with P&P, LCoE, and SMEs, and ensure readiness for audits.

This role focuses on driving procedural excellence and training integration across GPS functions. You will oversee updates, CAPAs, and training alignment while collaborating with senior leadership to improve process effectiveness in a fast-growing