Remote US Regulatory Strategy Lead for Biologics

Lundbeck; United States; Remote; USD 140,000 - 190,000; Full time

Job summary

Lundbeck seeks a Senior Manager, Regulatory Strategy (US RA) to drive US regulatory development and approval for brain health therapeutics, supporting both investigational and marketed biologics and drugs.

You will lead regulatory activities across the product lifecycle, review submission documents, liaise with FDA authorities, and guide cross-functional teams to ensure compliance with FDA regulations and guidance. 7+ years in pharma/biotech with 5+ years US RA are required.

Qualifications

• Bachelor’s degree in a life sciences field.
• 7+ years in pharma/biotech with 5+ years in US Regulatory Affairs.
• Experience in drug development and regulatory submissions.
• Strong risk assessment and scientific data interpretation.

Responsibilities

• Provide regulatory review of submission documents.
• Serve as US regulatory expert within cross-functional teams.
• Liaise with FDA authorities and manage submissions.
• Monitor US regulatory landscape to inform strategy.
• Lead regulatory activities across the product lifecycle and ensure FDA compliance.

Skills

US Regulatory Affairs

Regulatory Submissions

Cross-functional collaboration

Risk assessment

Education

Bachelor’s degree

Job description

Lundbeck seeks a Senior Manager, Regulatory Strategy (US RA) to drive US regulatory development and approval for brain health therapeutics, supporting both investigational and marketed biologics and drugs.

You will lead regulatory activities across the product lifecycle, review submission documents, liaise with FDA authorities, and guide cross-functional teams to ensure compliance with FDA regulations and guidance. 7+ years in pharma/biotech with 5+ years US RA are required.