Associate Director, GPS Standards & Training

Regeneron Ireland; Dublin; On-site; EUR 102,000 - 165,000; Full time

Benefits offered by this job

Annual bonuses

Equity awards

Pension or retirement benefits

401(k) company match

Health and wellness programs

Fitness centers

Insurance benefits (medical, dental, +

Paid time off

Family support benefits

Job summary

Regeneron Ireland seeks an Associate Director for Global Patient Safety Standards & Training to establish and maintain procedures aligned with PV regulations and industry standards. You will partner with P&P, LCoE, and SMEs to ensure training curricula reflect procedural updates and regulatory requirements.

The role involves leading GPS process design, ensuring audit readiness, and driving improved efficiency across the GPS framework while coordinating with senior management and cross-functional

Qualifications

• Bachelor's degree required.
• 7+ years in Pharmacovigilance/Drug Safety, Regulatory Affairs or QA.
• Thorough understanding of PV regulations and PV quality systems.
• Experience managing procedural updates.
• PV process design and optimization.
• Proven track record in audits/inspections.
• Ability to write procedural documents to quality standards.
• Collaborative cross-functional working with SMEs and process owners.

Responsibilities

• Update GPS procedures to reflect current regulatory expectations and ensure audit readiness.
• Coordinate procedural updates with P&P and LCoE, and align training curricula.
• Validate procedures with GPS Safety Operations leadership.
• Develop and maintain GPS procedures in line with Regeneron standards and industry best practices.
• Set risk-based prioritization for procedural updates across the GPS framework.
• Ensure correct procedural documents are included in the training curriculum.
• Oversee GPS Planned Process Deviations (PPDs) and GDQ approval criteria.
• Manage CAPAs and ensure timely closure with SMEs and process owners.
• Provide regular metrics on CAPAs, deviations, and training compliance.

Skills

Organizational skills

Procedural writing

Audits and presentations

Cross-functional collaboration

Education

Bachelor's degree

Job description

Regeneron Ireland seeks an Associate Director for Global Patient Safety Standards & Training to establish and maintain procedures aligned with PV regulations and industry standards. You will partner with P&P, LCoE, and SMEs to ensure training curricula reflect procedural updates and regulatory requirements.

The role involves leading GPS process design, ensuring audit readiness, and driving improved efficiency across the GPS framework while coordinating with senior management and cross-functional