Associate Director, Global Patient Safety Standards & Training

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking an

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking an Associate Director to join our Global Patient Safety Standards & Training team. Reporting to the Head of Global Patient Safety (GPS) Standards & Training, this position is responsible for establishing and maintaining procedures and policies consistent with Pharmacovigilance regulatory requirements and industry standards.

A key part of the role is close collaboration with the Process and Procedures (P&P) team and support of the Process Owner Network (PONs). The responsibilities of this job are foundational in the creation and maintenance of the Pharmacovigilance (PV) System that is essential in enabling the department, and therefore the company, to comply with regulatory PV requirements in all relevant territories worldwide, and to operate efficiently and effectively in alignment with established industry practices.

The role supports GPS activities and ensures procedures remain compliant with applicable global regulations as they evolve. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

• Work Location:
  
  Sleepy Hollow, NY, Warren, NJ or Cambridge, MA
• 4 days per week on site
• 25% Travel may be required

• Ensure that PV Intelligence updates are systematically assessed and reflected in GPS procedures, so that documented processes remain aligned with current regulatory expectations and the procedural framework is maintained in a state of audit and inspection readiness at all times.
• Act as a key liaison to Process & Procedures (P&P) and the Learning Centre of Excellence (LCoE) for procedural updates, so that procedural changes are accurately captured, appropriately sequenced, and correctly reflected in the associated training curriculum.
• As an SME, partner with the Head of GPS Safety Operations to validate that procedures are fit for purpose against safety practices, closing gaps between documented process and operational execution, including the mapping of procedural documents to regulations and to the training curriculum.
• Apply deep PV process design expertise to develop, implement, and maintain GPS procedures in alignment with regulations, Regeneron Standards, and industry best practices — in partnership with Process & Procedures (P&P), Process Owners, and SMEs — and lead the assessment of evolving global PV regulations.
• As a primary liaison to P&P, partner to set risk-based prioritization and sequencing in managing procedural updates across the GPS framework, in partnership with PONs and GPS Functional Leads.
• Assist in ensuring the correct procedural documents are assigned to the relevant training curriculum.
• Maintain oversight of and support for GPS Planned Process Deviations (PPDs), including guiding SMEs on meeting Global Development Quality (GDQ) approval criteria.
• Coordinate with P&P to align PPD expiration dates with queued procedure projects, adjusting prioritization as needed.
• Serve as GPS's escalation point for internal process and quality-event alignment challenges related to procedural updates, working in alignment with senior management and key stakeholders to investigate and resolve non-compliance.
• Manage, alongside the Process Owners, the content of procedures for GPS, escalating material gaps to senior management, including the maintenance and accuracy of PSMF Annex E in relation to GPS procedures.
• Maintain an overview of CAPAs associated with…