Senior Director, CMC Regulatory Strategy & Submissions

ModernaTX, Inc.; Norwood (MA); On-site; USD 225,000 - 405,000; Full time

Benefits offered by this job

Healthcare coverage

Bonuses/Equity

Generous time off

Job summary

ModernaTX, Inc. is seeking a senior Regulatory CMC leader based in Norwood, MA. You will manage a team of CMC experts, oversee agency correspondence and regulatory applications, and drive product strategy across the portfolio.

The role requires leading regulatory activities to produce high-quality CMC sections and communicating strategy to Manufacturing, Quality and Process Development teams. You will interface with department leadership, develop Reg CMC strategies, and ensure alignment with

Qualifications

• MS/PhD in a scientific/engineering discipline required.
• 10+ years in the pharmaceutical/biotech industry.
• 8+ years in Regulatory CMC, including DMF/ASMF submissions.
• Strong knowledge of US, EU, and ROW regulations.
• Experience with CTD format and regulatory filings.
• Exceptional written and oral communication.

Responsibilities

• Lead a team to develop/regulate CMC strategies for submissions (IND/CTA/BLA/MAA).
• Provide regulatory CMC expertise for product development projects.
• Review submission-readiness documents to meet guidelines.
• Lead CMC discussions with health authorities to facilitate approvals.
• Develop processes/procedures to support CMC submissions.
• Support creation/maintenance of CMC submission templates.
• Provide CMC regulatory expertise to manufacturing/quality teams.
• Interpret domestic/international guidance and advise on applicability.
• Oversee multiple programs across vaccines/oncology/rare diseases and drive strategy.

Skills

CMC regulatory

leadership

regulatory strategy

communication

Education

MS/PhD in scientific field

Job description

ModernaTX, Inc. is seeking a senior Regulatory CMC leader based in Norwood, MA. You will manage a team of CMC experts, oversee agency correspondence and regulatory applications, and drive product strategy across the portfolio.

The role requires leading regulatory activities to produce high-quality CMC sections and communicating strategy to Manufacturing, Quality and Process Development teams. You will interface with department leadership, develop Reg CMC strategies, and ensure alignment with