Global Regulatory Affairs Lead, Late-Stage

Kaztronix LLC; Radnor (Delaware County); On-site; USD 180,000 - 250,000; Full time

Job summary

Kaztronix LLC is seeking a Director of Regulatory Affairs to provide global leadership across late-stage development, regulatory submissions, and health authority interactions. You will drive strategy, ensure timely submissions, and lead cross-functional teams in a resource-constrained biotech environment.

The role requires hands-on execution, strong communication, and a proven track record in INDs, CTAs, DSURs, and global registrations with FDA and international authorities.

Qualifications

• Bachelor's degree in a scientific discipline is required.
• Advanced degree (MS, PharmD, PhD, or equivalent) preferred.
• 10–15 years of Regulatory Affairs experience.
• Experience in biotechnology/pharmaceutical industry, including late-stage development.
• Experience authoring and coordinating submissions (INDs, CTAs, DSURs, annual reports).
• Experience with FDA interactions and global health authority activities.

Responsibilities

• Develop and lead global regulatory strategies for programs.
• Represent Regulatory Affairs on cross-functional teams.
• Evaluate regulatory requirements and industry trends.
• Identify regulatory risks and mitigation strategies.
• Support integrated regulatory and development plans.
• Collaborate on FDA meetings and global registration strategy.
• Lead preparation and submission of regulatory documents.
• Provide hands-on leadership for US and international submissions.
• Ensure submissions are accurate and timely.
• Manage CROs and external consultants.
• Drive cross-functional alignment to meet milestones.
• Support NDA/BLA planning and post-approval activities.
• Interact with FDA and other health authorities.
• Lead regulatory briefing packages and responses.
• Monitor regulatory intelligence for project teams.
• Support due diligence and departmental initiatives.

Skills

Regulatory strategy

Regulatory submissions

FDA interactions

Cross-functional leadership

Project management

Regulatory risk assessment

Communication

Education

Bachelor's degree in a scientific discipline

Advanced degree (MS, PharmD, PhD)

Job description

Kaztronix LLC is seeking a Director of Regulatory Affairs to provide global leadership across late-stage development, regulatory submissions, and health authority interactions. You will drive strategy, ensure timely submissions, and lead cross-functional teams in a resource-constrained biotech environment.

The role requires hands-on execution, strong communication, and a proven track record in INDs, CTAs, DSURs, and global registrations with FDA and international authorities.