Director, U.S. 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

Director, U.S. Regulatory Lead – Immunology & Early Development

The Director, U.S. Regulatory Lead (USRL) is responsible for leading regulatory strategy and execution for post-approval immunology assets, with a focus on managing Postmarketing Commitments (PMCs) and Health Authority (HA) interactions. The incumbent will also serve as Global Regulatory Lead (GRL)/U.S. Regulatory Lead for an early-stage pulmonology asset, overseeing Investigational New Drug (IND) preparation, submission, and the development of U.S. regulatory strategies across all lifecycle phases.

Key Responsibilities

• Lead U.S. regulatory strategy and execution for post-approval immunology assets, including lifecycle management and fulfillment of PMCs and PMRs.
• Manage all FDA and Health Authority interactions related to PMCs, including briefing packages, response documents, and post-approval correspondence.
• Develop and maintain a comprehensive U.S. post-approval regulatory strategy, including label maintenance, annual reports, and lifecycle submissions.
• Partner with global regulatory and cross-functional teams to align regulatory strategies and ensure consistency in post-approval deliverables.
• Serve as Global Regulatory Lead (GRL)/U.S. Regulatory Lead (USRL) for an early pulmonology asset, leading preparation and filing of IND applications and developing regulatory components of the integrated development plan.
• Ensure regulatory documents and dossiers are compiled in compliance with applicable standards and guidelines.
• Provide oversight of external vendors supporting PMC documentation, submission management, and lifecycle maintenance.
• Proactively identify regulatory risks, assess impact, and propose mitigation strategies.

Qualifications

• Advanced scientific degree (Ph.D., M.D., PharmD, MS, or BS) required.
• 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.
• Proven success leading FDA interactions, including post-approval and pre-IND meetings.
• Pulmonology experience preferred but not required.
• Strong understanding of U.S. regulatory frameworks for lifecycle management, post-marketing commitments, and development transitions.
• Excellent written and verbal communication skills, with the ability to clearly articulate regulatory strategies and risks.
• Experience leading cross-functional matrix teams in a global environment.