ROLE
– Lead compilation, review, and finalization of dossiers for regulated markets
– Develop and finalize regulatory strategies for new product development
– Coordinate with stakeholders to obtain/verify documentation required for Modules 1–3
– Support regulatory impact assessment for CMC changes and ensure compliance with internal change control and global filing requirements
– Author and coordinate responses to FDA/EMA deficiency letters/queries
– Plan workload, mentor junior team members, and ensure high standards for document quality, formatting, and technical consistency across submissions
– Maintain up-to-date knowledge of FDA guidance, ICH guidelines, EU requirements, and relevant public domain information
– Lead and manage regulatory workload planning, prioritization, and performance delivery for regulated market programs
– Drive dossier compilation for complex injectable products/high-impact submissions and ensure first cycle approvals
– Ensure strong document control, version governance, and cross-functional document alignment
– Monitor regulatory intelligence and implement necessary updates into strategies and documentation standards
– Lead CFT communications and maintain submission traceability
– Apply risk identification and mitigation across regulatory programs to reduce approval delays

REQUIREMENTS
– Knowledge of FDA guidance, ICH guidelines, EU requirements, and relevant public domain information
– Experience with regulatory strategies for new product development
– Experience with CMC changes and internal change control
– Strong document control and version governance skills
– Ability to lead and manage regulatory workload planning, prioritization, and performance delivery
– Ability to drive dossier compilation for complex injectable products/high-impact submissions
– Ability to ensure strong cross-functional document alignment
– Ability to monitor regulatory intelligence and implement necessary updates
– Ability to apply risk identification and mitigation across regulatory programs