Director, US Regulatory Strategy & FDA Liaison

Lundbeck; Deerfield (IL); On-site; USD 200,000 - 230,000; Full time

Benefits offered by this job

Flexible PTO

Health benefits

401(k) match

Job summary

Lundbeck is a global biopharmaceutical company focused on brain health, seeking a Director, US Regulatory Affairs Strategy to lead regulatory plans for US products and coordinate cross-functional teams. You will oversee registrations, liaise with the FDA, and shape lifecycle management strategies in a collaborative environment.

The role requires extensive regulatory affairs experience, leadership in multinational teams, and a track record of successful FDA interactions.

Qualifications

• Bachelor's degree accredited in life sciences.
• 10+ years in pharma/biotech with 7+ years in Regulatory Affairs.
• Experience with small molecule and biological products.
• Regulatory management experience.
• Experience with FDA interactions (face-to-face, hybrid, and virtual).
• Ability to lead cross-functional/multinational teams.
• Proven leadership and staff development in regulatory strategy.
• Strong communication skills.

Responsibilities

• Serve as US/global product registration leader for US products, influencing cross-functional development teams and governance.
• Oversee assembly and creation of documentation for US FDA registration packages.
• Liaise with FDA for drug development, approvals, and post-approval activities.
• Provide high-level RA advice and identify regulatory requirements for clinical studies and marketing approvals.
• Serve as primary regulatory contact for alliance product brands and coordinate governance.

Skills

Regulatory strategy

FDA interactions

Cross-functional leadership

RA management

Team leadership

Strategic communication

Regulatory compliance

Education

Bachelor's degree

Life sciences degree

Master/PhD/MBA

Job description

Lundbeck is a global biopharmaceutical company focused on brain health, seeking a Director, US Regulatory Affairs Strategy to lead regulatory plans for US products and coordinate cross-functional teams. You will oversee registrations, liaise with the FDA, and shape lifecycle management strategies in a collaborative environment.

The role requires extensive regulatory affairs experience, leadership in multinational teams, and a track record of successful FDA interactions.