Global Regulatory CMC Director - Biologics Strategy Lead

Moderna; Norwood (MA); On-site; USD 180,000 - 240,000; Full time

Job summary

Moderna Associate Director, Global Regulatory-CMC will lead regulatory strategies for biologics or small molecules across lifecycle stages. You will shape global CMC plans, align with development teams, and drive submissions.

The role requires 5+ years in biologics CMC, experience with IND/CTA/BLA/MAA, CTD format, and global regulations, with strong cross-functional collaboration and health authority communication.

Qualifications

• 8+ years in pharma/biotech with 5+ years focused on biologics CMC.
• Experience with IND/CTA/BLA/MAA submissions and CTD format.
• Knowledge of global CMC regulations and regulatory procedures.

Responsibilities

• Develop and implement global CMC regulatory plans for submissions (IND/CTA/BLA/MAA).
• Provide guidance on CMC development and review submission documents.
• Lead interactions with health authorities.
• Assess manufacturing change controls.
• Support regulatory processes and templates.

Skills

Global regulatory-CMC expertise

Regulatory strategy leadership

Communication with health authorities

Cross-functional collaboration

Education

BS/MS/PhD in relevant scientific field

Job description

Moderna Associate Director, Global Regulatory-CMC will lead regulatory strategies for biologics or small molecules across lifecycle stages. You will shape global CMC plans, align with development teams, and drive submissions.

The role requires 5+ years in biologics CMC, experience with IND/CTA/BLA/MAA, CTD format, and global regulations, with strong cross-functional collaboration and health authority communication.