Global Regulatory CMC Lead - Strategy & Submissions

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

Benefits offered by this job

Competitive healthcare

Holistic well-being resources

Family planning benefits

Generous paid time off

Savings and investments

Location-specific perks

Job summary

Moderna is seeking an Associate Director, Global Regulatory-CMC to lead global regulatory CMC strategies and coordinate submissions across development stages. You will guide product teams, manage health authority interactions, and drive timely CMC approval while aligning with our transformative medicine priorities.

You will provide technical leadership, review documents for submission-readiness, and mentor teams in CTD-format submissions, manufacturing changes, and regulatory procedures,

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 current Global CMC regulations, including with CTD format and content of CMC regulatory submissions
• Knowledge of and broad experience with regulatory procedures and legislation related to CMC aspects for drug development, product registration, line extension and license maintenance

Responsibilities

• Develop/implement effective CMC regulatory strategies for global submissions (e.g. IND/CTA/BLA/MAA) and identify regulatory risks
• Provide guidance for regulatory CMC aspects of product development projects
• Review documents for submission-readiness, to ensure that all submissions conform to health authority guidelines
• Lead Regulatory CMC discussions and interactions with health authorities to facilitate review and approval of submissions
• Perform assessment of manufacturing change controls
• Support development of regulatory processes and procedures to support CMC components of regulatory submissions
• Support the creation and maintenance of CMC submission templates
• Provides CMC regulatory guidance to manufacturing and quality teams; evaluates CMC change controls
• Provides interpretation of regulatory guidance documents, regulations and directives – advises Manufacturing, Quality and Process/Analytical Development groups regarding their applicability and impact on internal programs

Skills

Regulatory CMC

Global regulatory knowledge

Strategic thinking

Communication skills

Cross-functional collaboration

Education

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

Job description

Moderna is seeking an Associate Director, Global Regulatory-CMC to lead global regulatory CMC strategies and coordinate submissions across development stages. You will guide product teams, manage health authority interactions, and drive timely CMC approval while aligning with our transformative medicine priorities.

You will provide technical leadership, review documents for submission-readiness, and mentor teams in CTD-format submissions, manufacturing changes, and regulatory procedures,