Global Regulatory Strategy Director for Phase 3 Biotech

Avalo Therapeutics; Chesterbrook (PA); On-site; USD 130,000 - 180,000; Full time

Job summary

Avalo Therapeutics in Chesterbrook, PA seeks a Director, Regulatory Affairs to lead the regulatory strategy for its lead asset, AVTX-009. The role demands a strategic and execution-focused leader who excels in cross-functional teams and regulatory submissions.

Ideal candidates will have 10-15 years of experience in Regulatory Affairs, preferably within biotechnology, and a strong understanding of FDA requirements. Join our mission to develop treatments that address significant unmet needs.

Qualifications

• 10-15 years of Regulatory Affairs experience within biotechnology/pharmaceutical industry.
• Minimum of 5 years experience within a small or emerging biotechnology company preferred.
• Experience interacting directly with FDA and managing regulatory submissions.

Responsibilities

• Design and implement global regulatory strategies.
• Serve as the Regulatory Affairs representative on project teams.
• Lead and coordinate routine regulatory submissions.

Skills

Regulatory Affairs experience

Strategic leadership

FDA interactions

Project management

Education

Bachelor's degree in a scientific discipline

Advanced degree (MS, PharmD, PhD)

Job description

Avalo Therapeutics in Chesterbrook, PA seeks a Director, Regulatory Affairs to lead the regulatory strategy for its lead asset, AVTX-009. The role demands a strategic and execution-focused leader who excels in cross-functional teams and regulatory submissions.

Ideal candidates will have 10-15 years of experience in Regulatory Affairs, preferably within biotechnology, and a strong understanding of FDA requirements. Join our mission to develop treatments that address significant unmet needs.