Director, Strategic Global Regulatory Compliance, Pharma

Aptar Group•Town of Clarkstown, NY

4d•$200,000 - $260,000•Hybrid

About The Position

Aptar Pharma, part of Aptar Group, specializes in Drug Delivery, offering innovative devices, services, and solutions focused on patient experience. Aptar Pharma has been setting the standard in drug delivery for decades, providing health technology solutions and services that enable effective patient treatment. The company emphasizes a culture of 'Be You, Be Aptar!' and is dedicated to improving health through science and technology.

Requirements

Bachelor's degree in Engineering, Life Sciences, Pharmacy, Regulatory Affairs, Quality, or related scientific discipline.
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.
Expert knowledge of FDA and global pharmaceutical GMP regulations
Expert knowledge of Combination Product regulations (21 CFR Part 4)
Expert knowledge of Medical Device regulations and ISO 13485
Expert knowledge of ISO 15378
Expert knowledge of Clinical trial regulatory requirements
Expert knowledge of Drug Services regulatory requirements
Expert knowledge of Quality system and compliance requirements applicable to pharmaceutical packaging, delivery systems, and services operations
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.

Nice To Haves

Advanced degree (MS, PharmD, MBA, or equivalent) preferred.

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 Aptar Pharma 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 Aptar Pharma.