Director, Strategic Global Regulatory Compliance, Pharma

Aptar Group; Congers (NY); On-site; USD 200,000 - 260,000; Full time

Benefits offered by this job

Competitive base salary

401(k) match

Comprehensive benefits (health, dental

Paid time off

Job summary

Aptar Pharma in Congers, NY is seeking a senior Regulatory Compliance leader to drive strategy, governance, and risk management across the Pharma segments. The role focuses on aligning compliance with business objectives and ensuring readiness for regulatory expectations.

The ideal candidate will lead regulatory affairs, quality systems, and remediation programs, interact with FDA and other agencies, and collaborate with senior leaders to enable compliant, sustainable growth for Aptar Pharma.

Qualifications

• Minimum 12 years of experience in pharmaceutical, 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.

Responsibilities

• Develop and maintain Pharma Segment Regulatory Compliance strategy aligned with business objectives.
• Establish enterprise-wide compliance governance processes and oversight mechanisms.
• Monitor regulatory compliance risks across Pharma divisions and sites.
• Provide strategic direction on regulatory interpretation and implementation for Aptar Pharma.

Skills

Regulatory compliance leadership

FDA/regulatory affairs

Quality systems awareness

Strategic influence

Education

Bachelor's degree in Engineering or Life Sciences

Job description

Improving Health through Science and Technology! AtAptar Pharma, we specialize in Drug Delivery offering Innovative Devices, Services and Solutions focused on Patient Experience.Aptar Pharma is part of Aptar Group, a global leader of dispensing systems for the packaging industry. Aptar Pharma has been setting the standard in drug delivery for decades providing health technology solutions and services enabling effective patient treatment.Be You, Be Aptar!

What You Will Do at Aptar Pharma:

Primary Duties and 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.

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 Aptar Pharma.

What Aptar Pharma Is 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.

What We Offer

• An exciting, diverse and value based working environment.
• Award-winning corporate university offering personal development and training opportunities.
• Competitive base salary
• Contribute to the communities where we reside.
• Innovative benefits plan which includes 401k plan with Company matching benefit, paid time off, medical, dental, vision, life, disability and more

Travel: Approx 25-35%; ability to travel to manufacturing sites, customer locations, industry forums and regulatory meetings as required.

Compensation and Base Annual Pay

In compliance with pay transparency requirements, the salary range for this role is USD $200,000.00 to USD $260,000 annually. This is not a guarantee of compensation or salary, as final offer amount may vary based on factors including but not limited to experience and geographic location. Aptar also offers a variety of benefits, including health, life, and disability insurance, 401(k) match and employer retirement savings contribution, flexible spending accounts, EAP, education assistance, parental leave, paid time off, company-paid holidays, and more. The specific programs and options available to an employee may vary depending on location, pay class, or other factors.

BE YOU, BE APTAR!

Aptar is an Equal Employment Opportunity (EEO) employer. It is the policy of the Company to provide equal employment opportunities to all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information.

Aptar Pharma, NA 250 Route 303 North Congers, NY 10920

www.aptar.com

Improving Health through Science and Technology!

Nearest Major Market: New York City