Global Regulatory Compliance Director: Strategy

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

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.