Global Regulatory CMC Director — Strategy & Submissions

Lundbeck; Deerfield (IL); On-site; USD 220,000 - 250,000; Full time

Benefits offered by this job

Flexible PTO

Health benefits (Medical, Dental, Visn

Vision

Job summary

Lundbeck seeks a Regulatory CMC leader to drive global regulatory strategies for innovative biologics throughout the lifecycle. You will collaborate with R&D, PM, Manufacturing, Quality, and Regulatory peers to ensure timely, high-quality submissions and robust CMC strategies.

The role requires extensive global submissions experience, strong communication, and ability to influence at all levels. Travel up to 10% internationally is expected.

Qualifications

• Eight years in Pharma/Biotech/Medical Device with CMC experience.
• Five years in Regulatory CMC with global program support.
• Ability to interact with CMC experts on process development and analytics.
• Proven success in global submissions, approvals, and lifecycle management.
• Ability to influence across peers and management levels.

Responsibilities

• Serve as regulatory CMC representative on development and marketed product teams.
• Advise on regulatory expectations and align CMC strategy with global plans.
• Manage interactions with Health Authorities for submissions and variations.
• Coordinate technical reports and CMC sections for global submissions.
• Ensure regulatory compliance and coordinate with CROs and partners.
• Evaluate manufacturing changes for global impact and provide guidance.
• Support CMC QA topics and regulatory-related matters.

Skills

Regulatory CMC experience

Global submissions

Leadership influence

Process development

Education

Bachelor's degree

Life sciences degree

Master or PhD in Science

Job description

Lundbeck seeks a Regulatory CMC leader to drive global regulatory strategies for innovative biologics throughout the lifecycle. You will collaborate with R&D, PM, Manufacturing, Quality, and Regulatory peers to ensure timely, high-quality submissions and robust CMC strategies.

The role requires extensive global submissions experience, strong communication, and ability to influence at all levels. Travel up to 10% internationally is expected.