Dr. Aze Baziz
Global R&D Regulatory Affairs
Johnson & Johnson
Basel, Switzerland
Global Regulatory Affairs Strategy Director-Leader with 20 years of extensive European-US-ROW regulatory experience in new product development, registration and lifecycle in Oncology, Immunology, Rare Diseases, CVR, Neuroscience in the biotech/pharma.
My organisation
About me
- Global Regulatory Affairs Strategy Director-Leader with 20 years of extensive global Europe-USA-International regulatory experience in biotech/pharmaceuticals sector.
- Worked in research and development on global overlapping development programs in early/late clinical development phases 1-4, new Marketing Authorisations (EU-CP, DCP, MRP, EU-national, CH, UK)/BLA/NDA applications, on novel biologics (mAb, ADC,...), combination products and small molecules in Oncology, Immunology, Rare Diseases, Inflammation, Cardiometabolic, Respiratory, GIT, Neuroscience and Medical Device. Worked at global matrix level with global multidisciplinary teams.
- Extensive regulatory experience in strategy development and implementation of global regulatory strategies, filing plans, and regulatory activities including CTAs (EU-CTR)/INDs, DSUR, IB, Pediatric Plans (PIP/PSP), Written Request, Orphan Drug (ODD), Scientific Advice, End of Phase 2 meeting, Briefing Book, pre-submission meetings with EMA/FDA/HC/European/International HAs, new MAA (EU-CP, UK, CH)/BLA/NDA applications, additional indications, extension of indications, peadiatrics, line extension, new combination products, new formulations/pharmaceutical form applications; as well as leadership of product portfolio lifecycle management.
- Served as Point of Contact (PoC) at the European Medicines Agency (EMA), and lead/co-lead interactions with the EMA, FDA, EU-nationals, MHRA, Swissmedic, HC, TGA, JP PMDA, CN NMPA, and international competent regulatory agencies and health authorities.
- Served as a Regulatory Representative/Subject Matter Expert among global product development teams/TAs Franchise, leadership and governance.
- - Extensive collaboration experience with stakeholders, Management, regions/affiliates and partners.
- In-depth knowledge and understanding of biotech/pharma industry business, geopolitics, regulatory policies trends, European-USA-international drug laws, regulations, EMA/FDA/WHO
guidelines, ICH guidelines and core processes for drug discovery, development, registration and commercial launch.