communication, training, and rollout coordination. Coordinate integration efforts across systems such as EHR (EMA), practice...
understanding of Current Good Manufacturing Practices (cGMP) and applicable regulatory guidelines (FDA, EMA, etc.) in an aseptic...
) Identify risks and mitigation strategies, ensuring compliance with industry regulations (e.g., GxP, FDA, EMA). Mentor junior...
, EMA, ICH, GCP, and GMP Provide person-in-plant support for drug product manufacturing Serve as the drug product subject..., ICH, FDA, and EMA requirements Proven ability to collaborate effectively across internal and external stakeholders Excellent...
experience with deep expertise in U.S. FDA, EMA, and international regulations within scientific and commercial contexts...
from FDA, EMA and other Rest-of-World (ROW) health authorities as needed. Oversee the electronic Quality Management System...
use Modernizing Medicine - EMA) Maintain adaptable and functional computer skills Respond to emergency situations based..., required SECTION 4: Knowledge, Skills and Abilities Requirements Thorough knowledge of medical terminology - required Prior EMA...
, peptide mapping, MAM, SEC‑MS, IEX‑MS, RP‑LC, native MS, and complementary biophysical methods. Solid knowledge of FDA, EMA...
, training, and rollout coordination. Coordinate integration efforts across systems such as EHR (EMA), practice management...
Experience with regulatory authorities and guidelines (FDA & EMA), including communication and documentation filing Fluent...