Global Regulatory CMC Strategy Lead

BioSpace; Norwood (MA); On-site; USD 143,000 - 257,000; Full time

Benefits offered by this job

Competitive healthcare

Well-being resources

Family planning benefits

Generous paid time off

Savings and investments

Location-specific perks

Job summary

Moderna is seeking a Global Regulatory CMC Lead to coordinate regulatory CMC activities across product life cycles and develop global strategies. You will guide product teams, prepare CMC/Quality agency correspondence, and manage multiple projects in a fast-paced environment to support transformative medicines.

The role requires 8+ years in pharma/biotech with biologics CMC experience, strong regulatory knowledge, and excellent communication. Hybrid in-office work with competitive benefits.

Qualifications

• BS/MS/PhD in molecular biology, pharmaceutics, chemistry, chemical engineering, or closely related field.
• 8+ years in the pharmaceutical/biotech industry with manufacturing and/or analytical focus.
• 5+ years of experience in biologics regulatory CMC.
• Strong knowledge of global CMC regulations, including CTD format and content.
• Experience collaborating in a dynamic cross-functional matrix.

Responsibilities

• Develop/implement global CMC regulatory strategies for global submissions (IND/CTA/BLA/MAA).
• Provide guidance for regulatory CMC aspects of product development projects.
• Review documents for submission-readiness, conforming to health authority guidelines.
• Lead Regulatory CMC discussions/interactions with health authorities.
• Assess manufacturing change controls.
• Support development of regulatory processes and procedures for CMC submissions.
• Support creation/maintenance of CMC submission templates.
• Provide CMC regulatory guidance to manufacturing and QA teams.

Skills

Regulatory CMC

Biologics

Cross-functional collaboration

Independent work

Written & verbal communication

Education

BS/MS/PhD in relevant field

Job description

Moderna is seeking a Global Regulatory CMC Lead to coordinate regulatory CMC activities across product life cycles and develop global strategies. You will guide product teams, prepare CMC/Quality agency correspondence, and manage multiple projects in a fast-paced environment to support transformative medicines.

The role requires 8+ years in pharma/biotech with biologics CMC experience, strong regulatory knowledge, and excellent communication. Hybrid in-office work with competitive benefits.