Global Regulatory Compliance Director: Strategy & Risk

Spherical Search Ltd.; New York (NY); On-site; USD 180,000 - 240,000; Full time

Job summary

Spherical Search Ltd partners with a global pharmaceutical leader to recruit a Director, Strategic Global Regulatory Compliance. The role leads regulatory compliance strategy across the pharma segment, with accountability for governance, risk management, and inspection readiness.

You'll manage regulatory intelligence across FDA, EMA, MHRA and other authorities, oversee remediation programs, and drive QMS harmonization.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Pharmacy, Regulatory Affairs, Quality, or related field.
• Advanced degree preferred.
• Minimum 12 years in pharmaceutical, combination product, medical device, or biologics industries.
• Minimum 5 years of leadership experience in Regulatory Compliance, Quality Systems, Regulatory Affairs, or related functions.
• Demonstrated experience interacting with FDA and other global regulatory agencies.

Responsibilities

• Develop and maintain the Pharma Segment Regulatory Compliance strategy aligned with business objectives and evolving global regulatory requirements.
• Establish enterprise-wide compliance governance processes and compliance oversight mechanisms.
• Monitor and assess regulatory compliance risks across all Pharma divisions and manufacturing sites.
• Provide strategic direction on interpretation and implementation of regulatory requirements impacting products and operations.
• Lead compliance risk assessments and trend analyses across quality, regulatory, manufacturing, supplier, and design control processes.
• Identify emerging compliance risks and develop mitigation strategies at the segment level.
• Establish risk-based compliance monitoring programs and metrics to drive continual improvement.
• Present compliance risk profiles and significant trends to Pharma Leadership and Executive Management.
• Lead the Pharma inspection readiness program for health authority inspections and customer audits.
• Monitor regulatory developments from FDA, EMA, MHRA, ANVISA, PMDA, Health Canada, NMPA and other relevant authorities.
• Translate regulatory intelligence into actionable business requirements and implementation plans.
• Coordinate enterprise-wide responses to significant changes in regulatory expectations.
• Provide oversight for significant compliance remediation initiatives arising from inspections, audits, assessments, warning letters, consent decrees, or other enforcement actions.
• Partner with divisional and site leadership to drive effective CAPA implementation and sustainable compliance improvements.
• Monitor execution and effectiveness of remediation activities across the Pharma segment.
• Ensure lessons learned are incorporated into business processes and quality systems.
• Develop and maintain Pharma-level compliance dashboards and key performance indicators.
• Analyze trends from audits, inspections, CAPAs, nonconformances, complaints, supplier issues, and regulatory observations.
• Prepare compliance reports for Pharma Leadership Team and Executive Management.
• Escalate significant compliance risks and recommend mitigation actions.
• Ensure alignment of segment-level quality management processes with applicable regulations and standards.
• Support harmonization of compliance processes across divisions and regions.
• Collaborate with Quality Systems leaders to maintain a regulatory-compliant QMS framework.
• Support Management Reviews through compliance risk assessments and strategic recommendations.
• Lead cross-functional and cross-divisional compliance initiatives.
• Mentor Quality and Regulatory professionals across the organization.
• Conduct compliance awareness and leadership training programs.
• Promote a culture of integrity, transparency, quality, and regulatory compliance throughout the Pharma business.

Skills

Regulatory leadership

Compliance risk mgmt

Inspection readiness

Regulatory intelligence

CAPA remediation

QMS oversight

Cross-functional leadership

Mentoring

Regulatory affairs

Executive communication

Education

Bachelor's degree in Engineering/Life Sciences/Pharmacy/Regulatory Affairs/Quality

Advanced degree (MS/PharmD/MBA) preferred

Job description

Spherical Search Ltd partners with a global pharmaceutical leader to recruit a Director, Strategic Global Regulatory Compliance. The role leads regulatory compliance strategy across the pharma segment, with accountability for governance, risk management, and inspection readiness.

You'll manage regulatory intelligence across FDA, EMA, MHRA and other authorities, oversee remediation programs, and drive QMS harmonization.