Strategic Director, Global Regulatory Compliance Pharma

Aptar Italia S.P.A.; Congers (NY); Hybrid; USD 200,000 - 260,000; Full time

Benefits offered by this job

401k match

Paid time off

Medical insurance

Dental insurance

Vision insurance

Life insurance

Disability insurance

Job summary

Aptar Pharma in the United States seeks a Director of Strategic Global Regulatory Compliance to lead regulatory strategy across pharma segments, ensuring alignment with FDA and global authorities. You will steer compliance governance, risk management, inspection readiness, and remediation programs to support safe, compliant drug delivery solutions.

This role requires 12+ years in pharma regulatory affairs, strong leadership, executive presence, and deep knowledge of GMP, 21 CFR Part 4, ISO

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Pharmacy, Regulatory Affairs, Quality, or related discipline.
• Minimum 12 years in pharmaceutical, device or biologics industries.
• Minimum 5 years in Regulatory Compliance, Quality Systems or related functions.
• Experience interacting with FDA and global regulatory authorities.

Responsibilities

• Lead Pharma Segment Regulatory Compliance strategy and governance.
• Monitor regulatory risks across divisions and sites; drive risk-based programs.
• Oversee inspection readiness for health authorities and audits.
• Drive remediation programs and CAPA across the organization.
• Develop dashboards and reports for Pharma Leadership.

Skills

Leadership

Regulatory affairs

FDA interaction

Quality systems

Regulatory intelligence

Strategic thinking

Executive presence

Education

Bachelor's degree in Engineering

Advanced degree preferred

Job description

Aptar Pharma in the United States seeks a Director of Strategic Global Regulatory Compliance to lead regulatory strategy across pharma segments, ensuring alignment with FDA and global authorities. You will steer compliance governance, risk management, inspection readiness, and remediation programs to support safe, compliant drug delivery solutions.

This role requires 12+ years in pharma regulatory affairs, strong leadership, executive presence, and deep knowledge of GMP, 21 CFR Part 4, ISO