Global CMC Regulatory Lead: Strategy & Submissions

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

Benefits offered by this job

Competitive healthcare

Well-being resources

Fitness and mental health support

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 CMC activities across product lifecycles and develop global regulatory strategies. You will guide product teams and manage multiple projects in a fast-paced environment to enable the next generation of medicines.

The role requires deep regulatory CMC experience, strong collaboration skills, and the ability to drive submissions through health authorities while maintaining alignment with business priorities.

Qualifications

• BS/MS/PhD in molecular biology, pharmaceutics, chemistry, chemical engineering, or closely related field is required.
• 8+ years of experience in the pharmaceutical/biotech industry, manufacturing and/or analytical focus.
• 5+ years of experience in biologics-focused Regulatory CMC.
• Strong knowledge of global CMC regulations, including CTD format/content.
• Knowledge of regulatory procedures and legislation related to CMC for drug development, registration, line extension, and maintenance.
• Ability to collaborate in a dynamic cross-functional matrix environment.
• Ability to work independently.
• Exceptional written and oral communication.

Responsibilities

• Develop/implement effective 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 and ensure compliance with health authority guidelines.
• Lead Regulatory CMC discussions with health authorities to facilitate reviews and approvals.
• Assess manufacturing change controls.
• Support development of regulatory processes for CMC submissions.
• Support creation/maintenance of CMC submission templates.
• Provide CMC regulatory guidance to manufacturing and quality teams; evaluate CMC change controls.
• Interpret regulatory guidance documents and advise on applicability and impact.

Skills

Regulatory CMC strategy

Cross-functional collaboration

Regulatory submissions

CTD knowledge

Communication

Project management

Independent work

Education

BS/MS/PhD in Molecular Biology, Pharmaceutics, Chemistry, Chemical Engineering, or related field

Tools

CTD format

Regulatory submission templates

Job description

Moderna is seeking a Global Regulatory CMC Lead to coordinate CMC activities across product lifecycles and develop global regulatory strategies. You will guide product teams and manage multiple projects in a fast-paced environment to enable the next generation of medicines.

The role requires deep regulatory CMC experience, strong collaboration skills, and the ability to drive submissions through health authorities while maintaining alignment with business priorities.