US Regulatory Strategy Director

Lundbeck A/S, H; Deerfield (IL); On-site; USD 200,000 - 235,000; Full time

Benefits offered by this job

Bonus target 25%

Medical, Dental & Vision

401k with company match

Flexible PTO

Job summary

Lundbeck seeks a Director, US Regulatory Affairs Strategy to oversee regulatory plans for US and global products. You will lead a cross-functional team, coordinate FDA interactions, and drive registrations from development through post-approval, ensuring compliance and strategic alignment.

Ideal candidates have 10+ years in pharma/biotech R&D with 7+ years in Regulatory Affairs, and prefer Deerfield, IL base with travel up to 20% domestically and possibly internationally.

Qualifications

• 10+ years R&D experience in pharma/biotech with 7+ years in Regulatory Affairs.
• Experience with small molecule and biologics regulatory programs.
• Proven leadership in cross-functional, matrixed teams.
• Experience with FDA interactions (face-to-face, hybrid, and/or virtual).
• Ability to navigate complex regulatory strategies.

Responsibilities

• Lead US product registrations, guiding cross-functional development teams.
• Prepare documentation for Investigational and Marketing applications for the US FDA.
• Liaise with FDA on drug development, approval, and post-approval activities.
• Provide high-level RA advice and identify US regulatory requirements.
• Train and manage a cross-functional regulatory affairs team.
• Monitor global regulatory changes and impact on product development.

Skills

Regulatory strategy

Cross-functional leadership

FDA interactions

Regulatory affairs oversight

Team leadership

Regulatory documentation

Strategic communication

Multi-national teams

Education

Bachelor’s Degree in life sciences

Master’s Degree or MBA

Doctorate Degree

Professional certifications

Job description

Lundbeck seeks a Director, US Regulatory Affairs Strategy to oversee regulatory plans for US and global products. You will lead a cross-functional team, coordinate FDA interactions, and drive registrations from development through post-approval, ensuring compliance and strategic alignment.

Ideal candidates have 10+ years in pharma/biotech R&D with 7+ years in Regulatory Affairs, and prefer Deerfield, IL base with travel up to 20% domestically and possibly internationally.