Director US Regulatory Strategy

Job overview

The Director US Regulatory Strategy is an onsite role based in Deerfield, IL, with a salary range of $200,000 to $235,000 per year. This position supports Lundbeck by overseeing regulatory strategies for drug and biological products in the United States. The role exists to ensure successful development and approval of products by liaising with the FDA and coordinating cross-functional teams. It contributes to the company's mission by advancing brain health through compliant and effective regulatory strategies.

What you'll do

• Oversee implementation of regulatory strategies.
• Serve as product registration leader for US products.
• Liaise with FDA for drug development and approval.
• Provide high-level RA advice.
• Serve as primary regulatory contact for alliance brands.
• Assess scientific data against regulatory requirements.
• Manage cross-functional regulatory teams.

What we're looking for

Skills & competencies

full-time

day shift

deerfield il

regulatory affairs

strategy

fda

biopharmaceutical

neuroscience

lundbeck

$200k-$235k

no on-call

Work arrangement

• Weekend coverage required

Benefits & perks

• 25% bonus target, 401(k) match, Medical, Dental, Vision, Flexible PTO

Why this role

Requires 10+ years R&D experience; 7+ years in Regulatory Affairs; 20% travel required.

About the employer

Lundbeck is hiring for this role. Industry: Administrative Management and General Management Consulting Services. Sector: 54.