US Regulatory Lead — Immunology & Early Development

VBeyond Corporation; United States; On-site; USD 150,000 - 200,000; Full time

Job summary

A leading biopharmaceutical company is seeking a Director, U.S. Regulatory Lead to oversee regulatory strategies for post-approval immunology assets. The successful candidate will lead interactions with FDA and manage the regulatory lifecycle for both approved and early-stage products. Requires an advanced scientific degree and significant experience in regulatory affairs, with strong communication and leadership skills.

Qualifications

• 7–10 years of regulatory affairs experience, with at least 3 years in U.S. regulatory leadership.
• Experience preparing and filing INDs and managing early development programs required.
• Pulmonology experience preferred but not required.

Responsibilities

• Lead U.S. regulatory strategy and execution for post-approval immunology assets.
• Manage all FDA and Health Authority interactions related to PMCs.
• Develop and maintain a comprehensive U.S. post-approval regulatory strategy.

Skills

Regulatory affairs

FDA interactions

Cross-functional leadership

Communication skills

Education

Advanced scientific degree (Ph.D., M.D., PharmD, MS, or BS)

Job description

A leading biopharmaceutical company is seeking a Director, U.S. Regulatory Lead to oversee regulatory strategies for post-approval immunology assets. The successful candidate will lead interactions with FDA and manage the regulatory lifecycle for both approved and early-stage products. Requires an advanced scientific degree and significant experience in regulatory affairs, with strong communication and leadership skills.