Global Regulatory CMC Strategy Lead

Biopharma Careers; Norwood (KY); On-site; USD 143,000 - 257,000; Full time

Benefits offered by this job

Competitive healthcare

Well-being programs

Family planning benefits

Generous PTO

Savings & investments

Job summary

Moderna in the United States is seeking a Global Regulatory CMC Lead to coordinate regulatory CMC activities across product lifecycles and develop global CMC strategies in line with business priorities. You will guide product teams and prepare CMC and quality agency correspondence and regulatory applications.

The role requires leading submissions (IND/CTA/BLA/MAA), managing multiple projects in a fast-paced environment, ensuring submission readiness, and driving regulatory milestones in

Qualifications

• 8+ years of pharmaceutical/biotech experience in regulatory CMC
• 5+ years of biologics-focused Regulatory CMC
• Strong knowledge of CTD format and CMC submissions
• Ability to work in a cross-functional matrix and communicate clearly

Responsibilities

• Develop/implement global CMC regulatory strategies for submissions (IND/CTA/BLA/MAA) and identify regulatory risks
• Provide guidance for regulatory CMC aspects of product development projects
• Review documents for submission-readiness per health authority guidelines
• Lead Regulatory CMC discussions with health authorities to facilitate approvals
• Perform assessment of manufacturing change controls
• Support development of regulatory processes to support CMC submissions
• Support creation and maintenance of CMC submission templates
• Provide CMC regulatory guidance to manufacturing and quality teams; evaluate CMC change controls

Skills

Regulatory strategy

Cross-functional collaboration

Independent work

Education

BS/MS/PhD in molecular biology/chemistry/pharmaceutics/chemical engineering

Tools

CTD format knowledge

Global CMC regulations

Job description

Moderna in the United States is seeking a Global Regulatory CMC Lead to coordinate regulatory CMC activities across product lifecycles and develop global CMC strategies in line with business priorities. You will guide product teams and prepare CMC and quality agency correspondence and regulatory applications.

The role requires leading submissions (IND/CTA/BLA/MAA), managing multiple projects in a fast-paced environment, ensuring submission readiness, and driving regulatory milestones in