Global Regulatory Strategy Lead – Late-Stage Drug-Device

Aerogen Pharma; North Carolina; Hybrid; USD 180,000 - 280,000; Full time

Benefits offered by this job

Relocation assistance

Flexible hybrid work

Job summary

Aerogen Pharma Limited is seeking a Senior Director, Global Regulatory Affairs to drive global regulatory strategy for late-stage drug-device programs. You will partner with the SVP of Regulatory Affairs and senior leadership to shape development plans, timelines, and regulatory submissions across US, EU, China and rest of world.

This role offers broad ownership, visibility, and the opportunity to influence portfolio strategy, lifecycle management, and regulatory excellence in a fast-paced,

Qualifications

• Bachelor’s degree in a scientific, medical, engineering, or related discipline.
• Advanced degree such as an MS, PharmD, PhD, MD preferred.
• 10+ years of regulatory affairs experience in pharma/biotech/combination-product.
• Proven global regulatory strategy leadership for development-stage products.
• Experience leading major marketing applications (MAA/NDA/BLA).

Responsibilities

• Act as accountable global regulatory leader for multiple programs.
• Advise SVP of Regulatory Affairs and cross-functional teams.
• Translate development objectives into global regulatory plans and timelines.
• Identify regulatory risks and mitigate accordingly.
• Mentor regulatory staff and build the future regulatory organization.
• Establish governance and operating standards for a growing company.
• Lead global strategy for late-stage drug-device products.
• Support inspections and launch readiness.

Skills

Global regulatory strategy

Cross-functional leadership

Executive communication

Strategy to execution

Education

Bachelor's degree

Advanced degree preferred

Job description

Aerogen Pharma Limited is seeking a Senior Director, Global Regulatory Affairs to drive global regulatory strategy for late-stage drug-device programs. You will partner with the SVP of Regulatory Affairs and senior leadership to shape development plans, timelines, and regulatory submissions across US, EU, China and rest of world.

This role offers broad ownership, visibility, and the opportunity to influence portfolio strategy, lifecycle management, and regulatory excellence in a fast-paced,