Associate Director, Global Patient Safety Standards – Training

Regeneron

. Establish and maintain procedures and policies consistent with Pharmacovigilance regulatory requirements and industry standards .

Posted 9/21/2026full-timeUnited StatesSenior💰 $157,200 - $256,600 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Pharmacovigilance regulatory requirements and quality management systems, with a strong focus on procedural development, training curriculum alignment, and process optimization. Proven ability to manage complex projects and collaborate effectively across functions to ensure compliance and operational excellence.

Highest-signal resume keywords

Pharmacovigilance RegulationsProcedural DevelopmentProject ManagementQuality AssuranceCross-Functional Collaboration

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

PharmacovigilanceRegulatory AffairsQuality Management SystemsProcedural DocumentationProcess DesignProcess OptimizationCAPA ManagementData PrivacyMetrics ReportingAudit Preparation

Soft Skills

Organizational SkillsCollaborative WorkPresentation Skills

Industry Keywords

Pharmaceutical IndustryBiotech IndustryGXP ComplianceGPS ProceduresTraining CurriculumProcess DeviationsSafety PracticesLearning Centre of Excellence

About the role

Key responsibilities & impact

Establish and maintain procedures and policies consistent with Pharmacovigilance regulatory requirements and industry standards
Collaborate with the Process and Procedures team and support the Process Owner Network
Ensure PV Intelligence updates are assessed and reflected in GPS procedures
Liaise with Process & Procedures and the Learning Centre of Excellence on procedural updates and training curriculum
Validate procedures against safety practices and close gaps between documented processes and operational execution
Develop, implement and maintain GPS procedures aligned with regulations, Regeneron Standards and industry best practices
Lead assessment of evolving global PV regulations
Set risk-based prioritization and sequencing for procedural updates
Ensure procedural documents are assigned to relevant training curriculum
Oversee GPS Planned Process Deviations and guide SMEs on GDQ approval criteria
Coordinate PPD expiration dates with queued procedure projects
Escalate and resolve internal process and quality-event alignment challenges
Manage GPS procedure content and maintain the accuracy of PSMF Annex E
Oversee CAPAs associated with procedures and ensure timely closure
Provide metrics on CAPAs, process deviations and training compliance to GPS leadership
Lead initiatives to improve GPS process effectiveness and efficiency
Present performance findings and recommendations to leadership
Liaise with Corporate and Clinical QA on GPS process and GXP-related impacts
Represent Standards & Training in audits and inspections
Serve as backup GPS Standards & Training liaison to the Learning Centre of Excellence

Requirements

What you’ll need

Minimum Bachelor's degree required; education in the life sciences is a strong plus
7+ years' experience in 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
Ability to write procedural documents to accepted standards of quality
Experience presenting in audits and inspections
Ability to work collaboratively across functions with SMEs, process owners and cross-functional partners
Experience with Data Privacy is a plus
25% travel may be required

Benefits

Comp & perks

Annual bonuses or other incentive plans
Equity awards
Pension or retirement benefits
401(k) company match
Health and wellness programs
Fitness centers
Medical, dental, vision, life and disability insurance benefits
Paid time off
Family support benefits
Reasonable accommodation during the recruitment process where required