). Demonstrated understanding of FDA, EMA and ICH guidelines. Strong interpersonal skills with the ability to work individually...
qualifications (URS, IQ/OQ/PQ). Compliance and Inspection Readiness Ensure operations meet FDA/EMA/PMDA/MHRA, USP/EP/JP...
as outlined for the position:LNW CMPLive Floor ViewSDSSTM/EMA and Servizio experience preferredAdditional RequirementsMust obtain...
and guidance. Knowledge and proven experience in FDA, EMA, or other regulatory authority. Demonstrated leadership, interpersonal...
activities, supporting inspection readiness for Food and Drug Administration (FDA) or European Medicines Agency (EMA) audits...
. Compliance & Quality Ensure regulatory documentation and submissions complywith ICH, FDA, EMA, MHRA, Health Canada, and regional... requirements (FDA, EMA, ICH). Strong vendor management experience. Strong stakeholder management skills. Excellent communication...
, IMPD, and Investigator's Brochure (specifically eCTD Module 4). Engage with regulatory authorities (FDA, EMA...
. Working knowledge of FDA, EMA, PMDA preferred. Familiarity with ICH, GxP, GMP, GCP, and commercial quality requirements...
with our company's standards and applicable FDA, EMA, ICH regulatory requirements. Support inspection readiness and the development...
, and EMA is a plus. Strong organizational skills and detailed documentation abilities are required. Work independently...