Biologics CMC: 10 years of regulatory work on monoclonal antibodies, hemophilia products, and combination products (auto-injector) under ICH, EMA, and FDA frameworks.

▪ Clinical-stage filings: Compiled IMPD and CTA for Itolizumab Phase 3 (EMA, ANVISA) and led an IND for a novel fusion mAb – submitted Jan 2020, US FDA approval Feb 2020.

▪ Orphan designations: EMA first-pass ODD (Itolizumab, aGVHD, Jan 2021) and US FDA ODD (anti-CD20 mAb, Jun 2019); scoring matrix helped avoid ~USD 30M in additional costs.

▪ Global reach: NDA roll-out across 53 countries; variation submissions for EU, Russia and MENA; annual reports and CMC updates for Health Canada, FDA, EMA and Nepal.

▪ Team leadership and Collaboration: Led a 10-member team on Scientific Advice packages to EMA, MHRA and Brazil (Aug 2020 – May 2021); leads cross-functional CMC and device teams.

▪ Regulatory intelligence: Built a prototype that automated agency-guidance monitoring and risk scoring, saving 10–20 hours of regulatory effort per project.

▪ Pipeline contribution: Core member of programmes behind 4 new products in oncology, diabetes and immune diseases.