Director, Strategic Global Regulatory Compliance, Pharma

AptarGroup, Inc.; Congers (NY); On-site; USD 200,000 - 260,000; Full time

Benefits offered by this job

401k match

Paid time off

Healthcare (medical)

Dental insurance

Vision insurance

Life insurance

Disability insurance

Education assistance

Job summary

Aptar Pharma is seeking a senior Regulatory Compliance leader to drive strategy, risk management and remediation programs across the Pharma segment. You will interact with FDA and global agencies, oversee QMS alignment, and influence cross-functional teams in a fast-paced, global environment.

This role requires deep expertise in pharmaceutical and medical device regulations, plus a proven track record of leading complex regulatory transformations and CAPA programs. Travel may be required.

Qualifications

• 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.

Responsibilities

• Regulatory Compliance Leadership: develop and implement Pharma segment regulatory compliance strategy.
• Compliance Risk Management: lead risk assessments and establish monitoring programs.
• Inspection Readiness & Regulatory Intelligence: lead readiness for health authority inspections and monitor regulatory developments.
• Regulatory Remediation & Compliance Programs: oversee remediation initiatives and CAPA effectiveness.
• Compliance Monitoring & Metrics: create dashboards and report trends to leadership.
• Quality Management System Oversight: align segment QMS with regs and standards.
• Leadership & Influence: mentor teams and drive regulatory culture across Aptar Pharma.

Skills

Leadership

Regulatory affairs

FDA interactions

Quality systems

Regulatory compliance

Education

Bachelor's degree in Engineering, Life Sciences, Pharmacy, Regulatory Affairs, Quality, or related scientific discipline

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

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 Pharmais 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

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 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.i>
• 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 isUSD $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. Aptaralso 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.

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