Executive Director, Regulatory Affairs

About the role

Beeline Medicines is seeking an Executive Director, Regulatory Affairs to lead global regulatory strategy for its innovative autoimmune and inflammatory disease programs. Reporting to the Senior Vice President, Regulatory Affairs & Quality, you will serve as the Global Regulatory Lead, ensuring timely preparation, review, and submission of IND, CTA, NDA, MAA and other marketing applications worldwide.

Key responsibilities

• Develop and execute global regulatory strategies for assigned product programs.
• Lead the preparation, review, and submission of IND, CTA, NDA, MAA and related marketing applications to regulatory authorities worldwide.
• Maintain existing marketing approvals and drive indication expansion in collaboration with cross‑functional teams.
• Manage global contractors/consultants and potentially direct reports.
• Represent Regulatory Affairs on multi‑disciplinary project teams and align department activities with company goals.

Required profile

• Extensive experience in regulatory affairs within the biotechnology or pharmaceutical industry.
• Proven track record of leading global regulatory submissions and strategy development.
• Strong leadership, collaboration, and proactive execution skills.
• Ability to work in a hybrid environment with at least two on‑site days per week.

Required skills

• IND/CTA/NDA/MAA preparation and submission.
• Global regulatory strategy development.
• Regulatory affairs leadership.
• Cross‑functional team collaboration.