Global Patient Safety Standards & Training Lead

Regeneron Pharmaceuticals, Inc.; New Jersey; On-site; USD 157,000 - 257,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. is seeking an Associate Director to join the Global Patient Safety Standards & Training team. Reporting to the Head of GPS Standards & Training, the role focuses on establishing procedures and policies aligned with pharmacovigilance regulatory requirements.

The role collaborates with P&P and PONs, develops training curricula, ensures audit readiness, and supports GPS activities worldwide, enabling Regeneron to maintain compliant PV systems.

Qualifications

• Minimum Bachelor's degree required in life sciences or related field.
• 7+ years' experience in Pharmacovigilance, Drug Safety, regulatory affairs, or QA.
• Thorough understanding of PV regulations and PV QMS.

Responsibilities

• Update PV procedures and align with global regulatory expectations.
• Collaborate with P&P and LCoE to reflect procedural changes in training curricula.
• Validate procedures with GPS Safety Operations and supervise CAPA activities.
• Lead PV process design improvements within GPS and ensure audit readiness.
• Coordinate with P&P to manage procedure updates and training assignments.

Skills

Pharmacovigilance

Regulatory affairs

Quality Assurance

Education

Bachelor's degree

Job description

Regeneron Pharmaceuticals, Inc. is seeking an Associate Director to join the Global Patient Safety Standards & Training team. Reporting to the Head of GPS Standards & Training, the role focuses on establishing procedures and policies aligned with pharmacovigilance regulatory requirements.

The role collaborates with P&P and PONs, develops training curricula, ensures audit readiness, and supports GPS activities worldwide, enabling Regeneron to maintain compliant PV systems.