Senior Manager Regulatory Strategy

Job overview

The Senior Manager, Regulatory Strategy (US RA) is an onsite role based in Waukegan, IL, with a salary range of $165,000 - $185,000 per year. This position supports the global biopharmaceutical company Lundbeck in its mission to advance brain health and transform lives through neuroscience innovation. The role exists to create and implement regulatory strategies for drug and biological products, ensuring successful development and approval. The incumbent will serve as a subject matter expert, represent the US regulatory perspective on cross-functional teams, and maintain compliance with FDA regulations throughout the product lifecycle.

What you'll do

• Provide regulatory review of documentation for FDA submissions
• represent US regulatory perspective at RAFT meetings
• act as primary FDA contact for assigned products
• monitor external regulatory climate
• manage submission assembly and creation
• provide high-level regulatory advice for clinical studies and marketing.

What we're looking for

Skills & competencies

full-time

day shift

waukegan il

lundbeck

regulatory strategy

fda

biotech

pharmaceutical

regulatory affairs

$165k-$185k

onsite

Work arrangement

• Weekend coverage required

Benefits & perks

• Flexible paid time off (PTO), medical, dental, vision, 401k with company match, and 15% bonus target.

Why this role

Requires 7+ years in pharma/biotech and 5+ years in US Regulatory Affairs; experience with biologics and CMC is preferred.

About the employer

Lundbeck is hiring for this role. Industry: Pharmaceutical Preparation Manufacturing. Sector: 32.