Associate Director, Global Patient Safety Standards & Training

Regeneron Pharmaceuticals, Inc (USA); North Carolina; On-site; USD 157,000 - 257,000; Full time

Benefits offered by this job

Annual bonuses

Equity awards

Pension/retirement benefits

401(k) company match

Health & wellness programs

Fitness centers

Insurance benefits

Paid time off

Family support

Job summary

Regeneron Pharmaceuticals, Inc (USA) is seeking an Associate Director to join the Global Patient Safety Standards & Training team. The role focuses on establishing and maintaining procedures aligned with PV regulatory requirements while collaborating with P&P and LCoE to keep training curriculums up to date.

You will lead PV process design, partner with SMEs, and ensure procedural documents map to regulations and training.

Qualifications

• 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.
• Experience with procedural updates and PV process design.
• Ability to write procedures and present in audits.

Responsibilities

• Update PV procedures to reflect regulatory changes.
• Coordinate with P&P and LCoE for curriculum updates.
• Partner with GPS Safety Operations to validate procedures.
• Lead PV process design and regulatory alignment.
• Manage GPS training content and CAPA oversight.

Skills

PV Regulations

Procedure drafting

Project management

Cross-functional collaboration

Audits & inspections

Education

Bachelor's degree in life sciences

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. 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:

• Minimum Bachelor's degree is required.
• Education in the life sciences is a strong plus.
• 7+ years' experience of 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.

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.

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

• 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

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 on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.

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.

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA‑approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases. Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.