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About the Role

This position is responsible for establishing and maintaining procedures and policies consistent with Pharmacovigilance regulatory requirements and industry standards. The role supports GPS activities and ensures procedures remain compliant with applicable global regulations as they evolve.

Responsibilities

• Ensure PV Intelligence updates are assessed and reflected in GPS procedures for alignment with regulatory expectations and audit readiness.
• Act as a liaison to P&P and LCoE for procedural updates, ensuring accurate capture and correct reflection in training.
• Partner with Head of GPS Safety Operations to validate procedures against safety practices and close gaps between documented process and execution.
• Develop, implement, and maintain GPS procedures in alignment with regulations, Regeneron Standards, and industry best practices.
• Partner with P&P to set risk-based prioritization and sequencing for procedural updates.
• Assist in ensuring correct procedural documents are assigned to the relevant training curriculum.
• Maintain oversight of and support for GPS Planned Process Deviations (PPDs).
• Coordinate with P&P to align PPD expiration dates with queued procedure projects.
• Serve as GPS's escalation point for internal process and quality-event alignment challenges related to procedural updates.
• Manage the content of procedures for GPS, escalating material gaps to senior management.
• Maintain an overview of CAPAs associated with procedures and ensure timely closure.
• Provide regular metrics on CAPAs, process deviations, and training compliance to GPS department leadership.
• Lead initiatives to enhance GPS process effectiveness and efficiency.
• Liaise with other functional teams on potential impacts to GPS Processes or GXP-related activities.
• Represent Standards & Training in audits and inspections.
• Serve as the back-up GPS Standards & Training liaison to LCoE.

Requirements

• Minimum Bachelor's degree required; life sciences education 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.

Skills

• Pharmacovigilance
• Drug Safety
• Regulatory Affairs
• Quality Assurance
• Process Design
• Document Management
• Project Management
• Organizational Skills
• Procedural Writing
• Audits and Inspections
• Collaboration
• Data Privacy

Location

• Sleepy Hollow, NY
• Warren, NJ
• Cambridge, MA

Work Type

• 4 days per week on site
• 25% Travel may be required

Experience Level

• Associate Director
• 7+ years' experience

Education Level

• Bachelor's degree

Salary/Compensations

• $157,200.00 - $256,600.00

Benefits

• Annual bonuses or other incentive plans
• Equity awards
• Pension or retirement benefits
• 401(k) company match
• Health and wellness programs
• Fitness centers
• Insurance benefits (e.g. medical, dental, vision, life and disability)
• Paid time off
• Family support benefits

About the Company

• Regeneron uses science and innovation to develop life-changing medicines for people with serious diseases.
• We are committed to building a workplace with an inclusive culture.
• Regeneron offers a competitive and comprehensive total rewards package.

Equal Opportunity

• Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law.
• Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.