Global Regulatory Affairs Director: Strategy & Submissions

Kaztronix LLC; Wayne (PA); On-site; USD 190,000 - 260,000; Full time

Benefits offered by this job

Health insurance

401(k) plan

Job summary

Kaztronix LLC seeks a strategic Director, Regulatory Affairs to guide global regulatory leadership across late-stage programs, from development through potential registration. You will lead submissions, health authority interactions, and lifecycle management in a fast-paced biotech environment.

The role requires hands-on execution, strong communication, and collaboration with cross-functional teams and senior leadership to drive milestones and ensure compliant, timely regulatory outcomes.

Qualifications

• Bachelor's degree in a scientific discipline; advanced degree preferred; 10–15 years in regulatory affairs.
• Experience supporting late-stage development and biologics; FDA interactions; CRO management.
• Proven ability to author and manage submissions (INDs, CTAs, BLA); strong communication.

Responsibilities

• Develop global regulatory strategies to support development, registration and lifecycle management.
• Lead regulatory submissions and manage health authority interactions.
• Collaborate with cross-functional teams and senior leadership.
• Oversee coordination with CROs and external consultants.
• Prepare regulatory briefing packages and respond to agency inquiries.

Skills

Regulatory strategy

Cross-functional leadership

FDA interactions

Submission execution

Biologics development

Education

Bachelor's degree in science

MS/PhD or PharmD preferred

Job description

Kaztronix LLC seeks a strategic Director, Regulatory Affairs to guide global regulatory leadership across late-stage programs, from development through potential registration. You will lead submissions, health authority interactions, and lifecycle management in a fast-paced biotech environment.

The role requires hands-on execution, strong communication, and collaboration with cross-functional teams and senior leadership to drive milestones and ensure compliant, timely regulatory outcomes.