Associate Director, Global Patient Safety & Training

Regeneron Pharmaceuticals, Inc.; United States; On-site; USD 150,000 - 190,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. seeks an Associate Director to lead Global Patient Safety Standards & Training.

This role develops and maintains PV procedures compliant with global regulations, collaborating with P&P and LCoE to ensure training aligns with the curriculum and regulatory expectations. Based in Sleepy Hollow, NY, Warren, NJ, or Cambridge, MA, the position is four days on site with travel up to 25%.

Qualifications

• Bachelor's degree required; life sciences preferred.
• 7+ years in pharmacovigilance or related fields.
• Strong knowledge of PV regulations and QMS.
• Experience updating procedures and training materials.
• Proven project management in document control.
• Excellent organizational and communication skills.
• Ability to author procedural documents to standards.

Responsibilities

• Ensure PV intelligence updates are reflected in GPS procedures.
• Liaise with P&P and LCoE for procedural updates and curricula.
• Validate procedures against safety practices and regulations.
• Develop and maintain GPS procedures in alignment with regulations, Regeneron standards, and industry best practices.
• Prioritize and sequence updates across the GPS framework with PONs and GPS leads.
• Align procedures with training curricula and PPD processes.
• Oversee GPS Planned Process Deviations and GDQ approvals.
• Coordinate PPD expiration dates with procedure projects.

Skills

Pharmacovigilance

Regulatory Affairs

Quality Assurance

Project Management

Procedural Writing

Process Design

Organizational Skills

Education

Bachelor's degree (Life sciences strongly preferred)

Job description

Regeneron Pharmaceuticals, Inc. seeks an Associate Director to lead Global Patient Safety Standards & Training.

This role develops and maintains PV procedures compliant with global regulations, collaborating with P&P and LCoE to ensure training aligns with the curriculum and regulatory expectations. Based in Sleepy Hollow, NY, Warren, NJ, or Cambridge, MA, the position is four days on site with travel up to 25%.