Senior Manager Regulatory Strategy

Job overview

The Senior Manager, Regulatory Strategy (US RA) is an onsite role based in Chicago, IL, with a salary range of $165,000 - $185,000 per year. This position supports the global biopharmaceutical company Lundbeck, which focuses exclusively on brain health, by implementing regulatory strategies for drug and biological products. The role exists to ensure successful US development and approval of products by participating in cross-functional teams and maintaining compliance with FDA regulations. The incumbent acts as the primary FDA contact, manages submission documentation, and monitors the external regulatory climate to inform long-term business objectives.

What you'll do

• Provides regulatory review of product documentation for FDA compliance.
• Represents US regulatory perspective at RAFT meetings.
• Acts as FDA contact for assigned products.
• Manages regulatory submissions.
• Monitors external regulatory climate.
• Leads compliance enhancement efforts.

What we're looking for

Skills & competencies

full-time

day shift

chicago il

lundbeck

regulatory strategy

fda

biotech

pharmaceutical

regulatory affairs

compliance

Work arrangement

• Weekend coverage required

Benefits & perks

• Flexible paid time off (PTO), medical, dental, vision, and company match 401k.

Why this role

Focus on brain health, global biopharmaceutical environment, and direct FDA liaison responsibilities.

About the employer

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