Senior Director, Regulatory Affairs CMC - Gene Therapy

Insmed seeks a Senior Director of Regulatory Affairs CMC for Gene Therapy to lead global regulatory strategy and submissions for gene therapy programs. Reporting to the VP of Regulatory Affairs, the role involves defining CMC strategies, managing regulatory submissions, and serving as the regulatory lead for cross-functional development teams from early-stage through post-approval lifecycle management.

Responsibilities

• Define, develop, and implement global regulatory CMC strategy plans for assigned programs
• Lead preparation of key regulatory dossiers including INDs, CTAs, CTRs, and briefing documents
• Identify and communicate CMC risks; develop and implement mitigation strategies
• Provide regulatory analysis and interpretation of FDA, EMA, PMDA, and ICH guidance to stakeholders
• Review CMC technical documentation and assess manufacturing and analytical changes for GMP compliance

Requirements

• Bachelor's degree in scientific discipline
• 10+ years global CMC regulatory affairs or pharmaceutical/biotech product development experience
• 5+ years gene therapy orphan/rare drug development experience
• Strong knowledge of US, EU, and Japanese biologics regulations including gene therapy
• Experience leading IND/CTA/CTR/IMPD submissions and global registration applications
• Demonstrated leadership of global CMC regulatory strategy for gene therapies across development lifecycle
• Experience with direct Health Authority interactions on complex regulatory matters