Manager I, Global Submission Management - CMC
Core
Lead end-to-end regulatory submission activities for CMC content, ensuring compliance and timely delivery of IND, IMPD, BLA, NDA, and marketing applications to global health authorities.
Role type
Manager I, Global Submission Management (Regulatory CMC)
Builds
Compliant regulatory submissions (eCTD) for pharmaceutical and biologics products
Domain
Life Sciences / Pharmaceutical Regulatory Affairs
Required skills
Global regulatory submission guidelines, CMC document management, eCTD publishing, risk and critical path management, project management, stakeholder collaboration, regulatory systems (Veeva RIM), manufacturing change management
Preferred skills
Module 3 content expertise, lifecycle management submissions, manufacturing process knowledge, regulatory impact assessments
Technologies
Veeva RIM, eCTD publishing systems, desktop software, AI/automation tools
Responsibilities
Define eCTD submission strategies and document requirements; execute submission management and publishing activities; track submission progress and manage critical paths; coordinate CMC contributions for health authority requests and inspections; drive continuous improvement in regulatory processes; manage submission readiness for lifecycle changes and variations.
Seniority
Manager I, hands-on leadership