Director, Strategic Global Regulatory Compliance

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

Director, Strategic Global Regulatory Compliance

About the Company

Our client is a global leader in pharmaceutical packaging, drug delivery systems, and healthcare technology, specialising in innovative devices, services, and solutions designed to improve patient outcomes and experience. With decades of experience in drug delivery, the organisation provides technology and solutions that enable effective patient treatment across global pharmaceutical markets.

Spherical Search are partnered with this organisation to identify a Director, Strategic Global Regulatory Compliance to join their global Pharma business.

What You Will Do

Primary Duties and Responsibilities

Regulatory Compliance Leadership

• 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.

Compliance Risk Management

• 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.

Inspection Readiness & Regulatory Intelligence

• 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.

Regulatory Remediation & Compliance Programs

• 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.

Compliance Monitoring & Metrics

• 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.

Quality Management System Oversight

• 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.

Leadership & Influence

• 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.

What We Are Looking For

• Bachelor's degree in Engineering, Life Sciences, Pharmacy, Regulatory Affairs, Quality, or related scientific discipline.
• Advanced degree (MS, PharmD, MBA, or equivalent) preferred.
• Minimum 12 years of experience 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.
• Strong knowledge of global pharmaceutical and medical device regulatory requirements.
• Proven record leading complex compliance remediation and transformation programs.

What You Will Bring on the Journey

Expert knowledge of:

• FDA and global pharmaceutical GMP regulations
• Combination Product regulations (21 CFR Part 4)
• Medical Device regulations and ISO 13485
• ISO 15378
• Clinical trial regulatory requirements
• Drug Services regulatory requirements
• Quality system and compliance requirements applicable to pharmaceutical packaging, delivery systems, and services operations

Segment Compliance Authority

Responsible for:

• Inspection readiness governance across all divisions.
• Regulatory intelligence and emerging compliance risk assessment.
• Oversight of significant compliance investigations, CAPAs, and remediation programs.
• Compliance metrics and management review reporting.
• Health Authority observation trending (483s, Warning Letters, Nonconformities).
• Compliance due diligence for acquisitions and new business opportunities.
• Governance of QMS harmonization from a compliance perspective.

Additionally

• Strong understanding of quality systems, risk management, CAPA, complaint handling, supplier quality, and management review processes.
• Ability to analyze complex compliance risks and develop practical business solutions.
• Executive presence with ability to influence senior leadership and drive organizational change.
• Excellent written and verbal communication skills.
• Strong strategic thinking and problem-solving capabilities.
• Ability to work effectively across global and matrix organizations.