Global CMC Regulatory Affairs Director - US Lead

Gan & Lee Pharmaceuticals USA Corp.; Northern (KY); On-site; USD 180,000 - 240,000; Full time

Job summary

Gan & Lee Pharmaceuticals USA Corporation is seeking its founding CMC Regulatory Affairs hire to serve as the primary gatekeeper for US CMC submissions and strategies. The role coordinates with the China-based team to ensure global regulatory compliance for FDA, EMA, and other markets.

The position requires a BS in a relevant science, 10+ years in CMC regulatory affairs with US/EU experience, and RAC or equivalent certification preferred.

Qualifications

• BS in Chemistry, Pharmaceutical Sciences, Biology, Chemical Engineering or related field.
• Advanced degree (MS, PhD or PharmD) strongly preferred.
• RAC or equivalent regulatory certification preferred.

Responsibilities

• Serve as US-based CMC regulatory gatekeeper for FDA, EMA and other authorities.
• Develop and execute CMC regulatory strategies aligned with global plans.
• Review and approve CMC submissions prepared by China HQ prior to filings.
• Coordinate timelines with China teams and resolve regulatory questions.
• Interact with regulatory authorities, including pre-submission meetings.
• Provide regulatory input to cross-functional product development teams.
• Support post-approval activities: supplements, variations, annual reports.
• Establish and maintain CMC SOPs and best practices for US affiliate.

Skills

Strategic thinking

Regulatory strategy

Analytical skills

Communication (English)

Cross-cultural collaboration

Project management

Self-directed

Regulatory documentation tools

Education

BS in Chemistry/Pharma/related

MS/PhD/PharmD preferred

RAC or equivalent preferred

Job description

Gan & Lee Pharmaceuticals USA Corporation is seeking its founding CMC Regulatory Affairs hire to serve as the primary gatekeeper for US CMC submissions and strategies. The role coordinates with the China-based team to ensure global regulatory compliance for FDA, EMA, and other markets.

The position requires a BS in a relevant science, 10+ years in CMC regulatory affairs with US/EU experience, and RAC or equivalent certification preferred.