Senior Manager Regulatory Strategy

Lundbeck; United States; On-site; 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

Role

Senior Manager, Regulatory Strategy (US RA) at Lundbeck, focusing on US regulatory development and approval of brain health therapeutics, supporting both investigational and marketed biologics and drugs.

Responsibilities

Responsibilities include providing regulatory review of submission documents, serving as US regulatory expert within cross-functional teams, liaising with FDA authorities, managing submissions, and monitoring US regulatory landscape to inform strategy.

The role requires leading regulatory activities throughout product lifecycle, ensuring compliance with FDA regulations and guidances, and advising on clinical and marketing regulatory requirements.

Qualifications

Qualifications: Bachelor’s degree, 7+ years in pharma/biotech with 5+ years in US Regulatory Affairs, demonstrated expertise in drug development, regulatory submissions, and risk assessment.

Strong scientific data interpretation, communication skills, and ability to work independently and in matrix teams are essential.

Preferred skills

Preferred skills include advanced degrees in science, biologic development experience, and familiarity with CMC.

High-value specifics

High-value specifics: biologics and drugs in the neuroscience space, US development lifecycle, regulatory submission management, and interacting with FDA.

Work setup

Work setup: Remote within the US, with ~5% domestic travel, primarily to the Deerfield, IL office if remote.