Senior CMC Regulatory Lead – Biologics (US & Canada)

Regulatory Jobs; North Carolina; On-site; USD 150,000 - 190,000; Full time

Job summary

Thermo Fisher Scientific in the United States seeks a seasoned CMC Regulatory Lead to steer global regulatory strategy for biological products and ensure compliant dossier delivery to FDA and Health Canada. You will own Module 3 content, coordinate cross-functional teams, and drive timely regulatory submissions.

The role requires a strong background in biologics CMC, regulatory intelligence, and lifecycle management, with capability to harmonize regional requirements and maintain post-approval

Qualifications

• Master's or PhD in biotechnology, pharma sciences or bioengineering.
• Global regulatory knowledge (EMA, ICH) for biologics.
• Proven CMC regulatory submissions leadership for biologics.
• Understanding of manufacturing, comparability and analytics.
• Strong project management and cross-functional collaboration.
• Excellent written and verbal communication in cross-border teams.

Responsibilities

• Lead development and execution of CMC regulatory strategies for biologics.
• Serve as SME on biologics and guide regulatory submissions to FDA/Health Canada.
• Coordinate with R&D, Quality, Manufacturing and Global Regulatory to align submission strategies.
• Oversee preparation, review and submission of CMC sections (Module 3) for biologics.
• Author and maintain CTD Module 3 content for regulatory filings.
• Respond to authorities' questions and deficiencies for CMC filings.

Skills

CMC strategy

Biologics expertise

Regulatory submissions

Cross-functional leadership

Project management

Regulatory communication

Education

Advanced biotech degree

Job description

Thermo Fisher Scientific in the United States seeks a seasoned CMC Regulatory Lead to steer global regulatory strategy for biological products and ensure compliant dossier delivery to FDA and Health Canada. You will own Module 3 content, coordinate cross-functional teams, and drive timely regulatory submissions.

The role requires a strong background in biologics CMC, regulatory intelligence, and lifecycle management, with capability to harmonize regional requirements and maintain post-approval