Global Regulatory CMC Strategy Lead

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

Benefits offered by this job

Competitive healthcare

Discretionary annual bonus

Equity option

Job summary

Moderna Therapeutics is seeking an Associate Director of Global Regulatory Affairs, CMC, to oversee CMC and Quality agency correspondence and regulatory applications for global products.

You will lead regulatory activities, ensure high-quality CMC sections, and manage multiple projects in a fast-paced environment to advance transformative medicines. This role supports a 70/30 in‑office work model and a collaborative, in-person culture.

Qualifications

• 10+ years of experience in the pharmaceutical/biotech industry, manufacturing and/or analytical focus.
• 8+ years of experience in Biologics focused Regulatory CMC multidisciplinary focus on vaccines, oncology and/or rare diseases.
• Strong knowledge of current EU and ROW regulations.
• Strong knowledge of cGMP and CTD format and content regulatory filings.
• Exceptional written and oral communication.

Responsibilities

• Develop and implement effective CMC regulatory strategies for international submissions (IND/CTA/BLA/MAA) and identify regulatory risks.
• Provide guidance on regulatory CMC aspects of product development projects.
• Review documents for submission readiness and conformity to health authority guidelines.
• Lead Regulatory CMC discussions and interactions with health authorities to facilitate review and approval of submissions.
• Develop regulatory processes and procedures to support CMC components of regulatory submissions.
• Support creation and maintenance of CMC submission templates.
• Provide CMC regulatory guidance to manufacturing and quality teams; evaluate CMC change controls.
• Interpret regulatory guidance documents, regulations, and directives and advise on applicability and impact on internal programs.
• Lead oversight of multiple programs in various therapeutic areas (vaccines, oncology, and/or rare diseases).

Skills

Regulatory CMC

IND/CTA/BLA/MAA

Regulatory strategy

Cross-functional leadership

Regulatory submissions

Education

BS in Pharmaceutics, Chemistry, Chemical Engineering

MS in Pharmaceutics, Chemistry, Chemical Engineering

Tools

CTD format

Job description

Moderna Therapeutics is seeking an Associate Director of Global Regulatory Affairs, CMC, to oversee CMC and Quality agency correspondence and regulatory applications for global products.

You will lead regulatory activities, ensure high-quality CMC sections, and manage multiple projects in a fast-paced environment to advance transformative medicines. This role supports a 70/30 in‑office work model and a collaborative, in-person culture.