Associate Director, Global Regulatory, CMC

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

Role

Associate Director, Global Regulatory-CMC, leading regulatory strategies for biologics or small molecules across all lifecycle stages.

Responsibilities

develop and implement global CMC regulatory plans for submissions (IND/CTA/BLA/MAA), provide guidance on CMC development, review submission documents, lead interactions with health authorities, assess manufacturing change controls, and support regulatory processes and templates.

Requirements

BS/MS/PhD in a relevant scientific field, 8+ years in pharma/biotech with 5+ years focused on biologics CMC, strong knowledge of global CMC regulations, CTD format, and regulatory procedures.

Preferred

ability to collaborate cross-functionally, work independently, and communicate effectively.

High-value

biologics, regulatory CMC strategy, global submissions, manufacturing change assessment, interaction with health authorities, applicable to late-stage development or post-market biologic products.

Work setup

Not specified; location/modality and travel not detailed.