of various pharmaceutical dosage forms. Preferred direct experience with Health Authority Inspections (FDA/EMA, ANVISA...
. · Strong understanding of FDA, EMA, ICH, USP, and EP guidelines and regulations associated with the quality control of viral vectors, cell...
Journeyman License, NACE CIP 1, 2, 3, EMA (Expediting Management Association) Basic, Advanced, ASNT NDT Level II, III, and ASQ...
, and commissioning efforts in compliance with GMP, FDA, EMA, and cybersecurity standards. Supporting digital transformation initiatives... projects Experience with regulatory compliance (FDA, EMA) and GMP requirements for synthetic molecule manufacturing...
, ensuring alignment with international regulatory requirements (e.g., FDA, EMA, NMPA). Provide expert advice and oversight... interactions and negotiations with regulatory authorities (FDA, EMA, etc.) on DMPK-related matters, including pre-IND/NDA meetings...
Experience with regulatory authorities and guidelines (FDA & EMA), including communication and documentation filing Fluent...
qualification, assay lifecycle and method validation per ICH/FDA/EMA guidance. Sustain a working understanding of regulatory...
standards like FDA, EMA, and EU Annex 1. Leading innovation efforts by evaluating and introducing new clean utility...
programs, and biologics manufacturing controls. Strong understanding of global regulatory expectations (e.g., FDA, EMA...
—features EMA and FDA-approved manufacturing suites, fill/finish capabilities, labs, and warehousing to support Phase 3 through...