Associate Director, Global Patient Safety Standards & Training

BioSpace; New Jersey; On-site; USD 157,000 - 257,000; Full time

Job summary

Regeneron is seeking an Associate Director for the Global Patient Safety Standards & Training team. You will establish and maintain PV procedures compliant with global regulations and collaborate with P&P, LCoE, and SMEs to align training curricula.

The role requires 7+ years in PV/QA, deep PV process design experience, and the ability to drive audits and inspections while leading cross-functional initiatives. Onsite work is required in multiple locations with travel.

Qualifications

• Bachelor's degree required; life sciences is a plus.
• 7+ years in Pharmacovigilance/Drug Safety, Regulatory Affairs or Quality Assurance.
• Thorough understanding of PV regulations and PV QMS.
• Extensive experience managing procedural updates.
• Experience in PV process design and optimization.
• Track record of successful project management related to document management.

Responsibilities

• Ensure PV intelligence updates are reflected in GPS procedures and training readiness.
• Liaise with P&P and LCoE for procedural updates and curriculum alignment.
• As SME, validate procedures are fit for purpose against safety practices and regulations.
• Develop, implement, and maintain GPS procedures aligned with regulations and industry best practices.
• Lead prioritization and sequencing of procedural updates across the GPS framework with PONs.
• Ensure correct procedural documents are assigned to the training curriculum.
• Oversee GPS Planned Process Deviations and GDQ approval criteria.
• Coordinate with P&P to align PPD dates with procedure projects and adjust timelines.
• Escalate and resolve non-compliance through senior management and stakeholders.
• Manage content of GPS procedures with Process Owners; ensure CAPA closure and training timing.
• Provide metrics on CAPAs, deviations, and training compliance to GPS leadership.
• Lead initiatives to improve GPS process effectiveness and performance metrics.
• Regularly liaise with Corporate and Clinical QA on GPS impacts or GXP activities.
• Represent GPS Standards & Training in audits and inspections.
• Backup GPS Standards & Training liaison to LCoE.

Skills

PV regulations

PV process design

Project management

Technical writing

Audits & inspections

Cross-functional collaboration

Education

Bachelor's degree

Job description

Build Our Future Together 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.

Build Our Future Together 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.

When & Where

Work Location: Sleepy Hollow, NY, Warren, NJ or Cambridge, MA

4 days per week on site

25% Travel may be required

Discover Your Role

• 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 procedures, including those arising from both audits and inspections, and work closely with SMEs, PONs and the P&P team to ensure timely CAPA closure, including allowing appropriate time for associated training.
• Provide regular metrics on CAPAs, process deviations, and training compliance to GPS department leadership.
• Lead initiatives to enhance GPS process effectiveness and efficiency, including the analytical framework for performance metrics, and present findings and recommendations to leadership.
• Liaise regularly with other functional teams e.g. Corporate and Clinical QA 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.

This Role Requires

1. Minimum Bachelor's degree is required. Education in the life sciences is a strong plus.
2. 7+ years' experience of Pharmacovigilance/Drug Safety, Regulatory Affairs or Quality Assurance in the pharmaceutical/biotech industry.
3. Thorough understanding of Pharmacovigilance/Drug Safety regulations and PV Quality Management Systems.
4. Extensive experience managing procedural updates.
5. Experience in PV process design and optimization.
6. Track record of successful project management relevant to document management.
7. Strong organizational skills.
8. Ability to write procedural documents to accepted standards of quality.
9. Experience presenting in audits and inspections.
10. Ability to work collaboratively across functions with SMEs, process owners and cross-functional partners.
11. Experience with Data Privacy is a plus

We are committed to building a workplace with an inclusive culture. 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.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: 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, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually) $157,200.00 - $256,600.00