Global Regulatory Affairs Director – Biotech

Avalo Therapeutics; Philadelphia (Philadelphia County); On-site; USD 180,000 - 240,000; Full time

Job summary

Avalo Therapeutics is seeking a strategic and execution-focused Director, Regulatory Affairs to provide global regulatory leadership for abdakibart (AVTX-009) as it advances into Phase 3 and potential registration. This role leads regulatory strategy, submissions, and interactions with FDA and international authorities.

The ideal candidate has 10–15 years of Regulatory Affairs experience in biotech/pharmaceuticals, with a track record in late-stage development and biologics, and a strong ability

Qualifications

• Bachelor's degree in scientific discipline required.
• 10–15 years of Regulatory Affairs experience within biotech/pharmaceutical industry.
• Minimum of 5 years of experience within a small or emerging biotechnology company preferred.
• Experience supporting late-stage clinical development programs and biologics preferred.
• Proven experience authoring, reviewing, and managing a broad range of regulatory submissions (INDs, CTAs, DSURs, annual reports, briefing packages).

Responsibilities

• Design, lead, and implement global regulatory strategies for development, registration, and lifecycle management.
• Serve as Regulatory Affairs representative on cross-functional project teams and provide strategic guidance.
• Evaluate evolving regulatory requirements and assess impacts on development strategy.
• Identify regulatory risks and communicate recommendations to leadership.
• Lead preparation and submission of regulatory documents throughout product lifecycle.
• Interact with FDA and ex-U.S. regulatory agencies and manage CROs/consultants.

Skills

Regulatory strategy

Leadership

Cross-functional collaboration

FDA interactions

IND/CTA submissions

Biologics development

Project management

Global regulatory

Education

Bachelor's degree in science

Advanced degree preferred

Job description

Avalo Therapeutics is seeking a strategic and execution-focused Director, Regulatory Affairs to provide global regulatory leadership for abdakibart (AVTX-009) as it advances into Phase 3 and potential registration. This role leads regulatory strategy, submissions, and interactions with FDA and international authorities.

The ideal candidate has 10–15 years of Regulatory Affairs experience in biotech/pharmaceuticals, with a track record in late-stage development and biologics, and a strong ability