CMC Regulatory Strategy Director

BioSpace; Norwood (MA); On-site; USD 225,000 - 405,000; Full time

Benefits offered by this job

Healthcare coverage

Well-being resources

Family planning benefits

Paid time off

Job summary

Moderna is seeking a leader to manage a team of CMC experts in Norwood, MA, overseeing regulatory correspondence and applications, shaping product strategy, and guiding regulatory activities to produce high-quality CMC sections for submissions.

You will lead interactions with health authorities, develop processes to support regulatory submissions, and ensure alignment with global guidelines across multiple therapeutic areas. Strong communication and strategic oversight are essential to success.

Qualifications

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

Responsibilities

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

Skills

Regulatory strategy

Team leadership

Regulatory submissions

Communication skills

Education

MS/PhD in science/engineering

Job description

Moderna is seeking a leader to manage a team of CMC experts in Norwood, MA, overseeing regulatory correspondence and applications, shaping product strategy, and guiding regulatory activities to produce high-quality CMC sections for submissions.

You will lead interactions with health authorities, develop processes to support regulatory submissions, and ensure alignment with global guidelines across multiple therapeutic areas. Strong communication and strategic oversight are essential to success.