Associate Director, Global Regulatory, CMC

Role Overview

The Associate Director, Global Regulatory-CMC will coordinate regulatory CMC activities for one or more products throughout their lifecycle, develop global regulatory CMC strategies, collaborate with stakeholders, and manage multiple projects to support the delivery of transformative medicines.

Key Responsibilities

• Develop and implement effective CMC regulatory strategies for global submissions (IND, CTA, BLA, MAA) and identify regulatory risks.
• Provide guidance on regulatory CMC aspects of product development projects.
• Review documents for submission readiness, ensuring compliance with health authority guidelines.
• Lead regulatory CMC discussions and interactions with health authorities to facilitate review and approval of submissions.
• Assess manufacturing change controls.
• Support development of regulatory processes and procedures for CMC components of regulatory submissions.
• Create and maintain CMC submission templates.
• Provide CMC regulatory guidance to manufacturing, quality, and process/analytical development groups.
• Interpret regulatory guidance documents, regulations, and directives; advise on applicability and impact on internal programs.

Basic Qualifications

• BS, MS, or PhD in Molecular Biology, Pharmaceutics, Chemistry, Chemical Engineering, or closely related field.
• 8+ years of experience in the pharmaceutical/biotech industry with manufacturing and/or analytical focus.
• 5+ years of experience in biologics-focused regulatory CMC.
• Strong knowledge of current global CMC regulations, including CTD format and content of CMC regulatory submissions.
• Broad experience with regulatory procedures and legislation related to CMC aspects for drug development, product registration, line extension, and license maintenance.

Preferred Qualifications

• Ability to collaborate effectively in a dynamic, cross‑functional matrix environment to meet program regulatory milestones.
• Ability to work independently.
• Exceptional written and oral communication skills.
• Desire to make an impact in a high-growth, transformational company.

Pay & Benefits

• Salary range: $142,500.00 - $256,500.00.
• Best-in-class healthcare coverage, voluntary benefit programs.
• Well‑being resources including fitness, mindfulness, mental health support.
• Family planning benefits (fertility, adoption, surrogacy).
• Generous paid time off (vacation, volunteer days, sabbatical, global recharge days, discretionary year‑end shutdown).
• Savings and investment opportunities.
• Location‑specific perks and extras.

Equal Opportunity Employer

Moderna is committed to equal employment opportunity and non‑discrimination for all employees and qualified applicants without regard to race, color, sex, gender identity or expression, age, religion, national origin, ancestry, citizenship, ethnicity, disability, military or veteran status, genetic information, sexual orientation, marital or familial status, or any other characteristic protected under applicable law. Moderna is an E‑Verify Employer in the United States. We consider qualified applicants regardless of criminal histories in accordance with legal requirements.