Navigating Risk and Change - Day 2

Mandy holds a Master’s degree in Chemistry and brings over 20 years of extensive experience in the pharmaceutical industry, specializing in quality control, quality assurance, and regulatory affairs. She possesses deep expertise in managing regulatory filings, delivering exceptional customer support, and driving the implementation of compliant regulatory processes across diverse business functions.

Dr. Janmeet Anant, PMP, RAC, is a Senior Regulatory Consultant with over 25 years of experience in biopharmaceutical manufacturing, specializing in sterile injectables. He is a member of the Regulatory Governance Team at BioPhorum and part of the PDA’s Paradigm Change in Manufacturing Operations team, focusing on quality risk management and post-approval change strategies. Janmeet has held leadership roles in the Bioprocess Systems Alliance and ASME-BPE, and supports CMC submissions for mAbs, viral vectors, and ADCs in the CDMO regulatory team. He holds a Ph.D. in Pharmacology and certifications in project management and regulatory affairs.

Houda is an experienced CMC Regulatory Leader with extensive expertise in both US and EU regulatory environments, specializing in development and initial Module 3 for MAA/J-NDA/BLA filings, alongside lifecycle management. This included Advanced Therapy Medicinal Products and others Biological Products. She has more than 17 years of CMC Regulatory experience in the pharmaceutical industry and Biotech. She is based in France and currently heads the Biopharma Regulatory Experts team, within Regulatory Management. She is member of the EuropaBio Working group on Orphans & ATMPs. She is also member of A3P – GIC Bioprocess (Common Interest Groups), French Association.

Mike holds a Bachelor’s degree in Biology and brings over ten years of extensive experience in regulatory affairs. He specializes in providing regulatory support for both Excipient and Active Pharmaceutical Ingredient (API) portfolios. Mike is proficient in managing FDA registrations and overseeing National Drug Code (NDC) assignments for API products. Additionally, he has contributed to the development of regulatory guidance documents and led the GMP comparison working group for IPEC Americas, demonstrating his commitment to industry standards and regulatory excellence.

June has over 16 years in life sciences and biopharma. With over 13 years of experience, she specializes in upstream/downstream processing, single-use systems, and continuous bioprocessing. She leads solutions for ADCs across APAC (excluding China), focusing on process efficiency and customer needs. June previously served as Global Go-to-Market Lead for Clarification, Upstream Systems, and Mixers portfolios.

Jeong-Hoon has 12+ years of experience in the pharmaceutical and life science industry. He has expertise in Quality Assurance for solid oral dosage forms and biopharmaceutical raw materials. In his current role, he provides customer training programs, provides local regulatory support for products licenses of Korean customers, reviews regulatory requirements for imported medical devices, food additives, and biopharmaceutical raw materials, and monitors regulatory trends.

Rain has over 10 years of experience in chemistry, life sciences, and bioprocessing, specializing in upstream applications from cell line development to fed-batch and continuous perfusion. She leads go-to-market strategy for upstream innovations in APeC (Asia Pacific excluding China), blending technical expertise with commercial insight. Rain supports emerging biotech, CDMOs, and large biopharma, building lasting partnerships to drive innovation and growth.

Saroj's current responsibilities include monitoring regulatory trends, commenting on guidelines, and representing the company at authority events and meetings. She has 10+ years experience in R&D, product management & regulatory management. She holds a Ph.D. in biotechnology from Institute of Chemical Technology.