CTD/eCTD dossier strategy and lifecycle management

IND, ANDA, CTA and global submissions coordination

Module 3 gap assessments and remediation planning

GMP, GLP, CAPA, OOS investigations and audits

Monitoring global regulatory changes and guidance

Responses to deficiency letters and agency queries

Veeva Vault RIM deployment and validation

Documentum, structured content and archive workflows

AI-assisted writing tools & regulatory platforms (CAPTIS)

Regulatory data analytics to identify compliance gaps

Workflow automation and process improvements

Training RA teams on RIM and document workflows

Managing CMC writer teams and cross-functional groups

End-to-end project delivery for regulatory programmes

Working with QA, QC, Development and external partners

Leading process and system change initiatives

Defining long-term regulatory and operational strategy

Coaching team members and building capability