Executive Director, CMC Regulatory Science

About the Role Based at the Norwood, MA site, this Executive Director will lead a team of CMC experts responsible for preparing and overseeing CMC and Quality-related agency correspondence and regulatory applications. The role requires shaping product strategy across the portfolio and guiding all regulatory activities to deliver high-quality CMC sections of regulatory documentation, with clear communication across leadership. What You'll Do

• 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
• Provides CMC regulatory expertise to manufacturing and quality teams; evaluates CMC change controls
• Provides 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. Be a site expert.
• Lead oversight of multiple programs in various therapeutic areas (vaccines, oncology and/or rare diseases) and drive Reg CMC strategy successfully What We're Looking For
• 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 Nice to Have
• MS/PhD degree in Molecular Biology, Pharmaceutics, Chemistry, or closely related field is desirable
• 10+ years of experience in the pharmaceutical/biotech industry, manufacturing and/or analytical focus
• 8+ years of experience in Biologics focused Regulatory CMC Compensation & Benefits
• Details not provided in posting.