regulatory requirements (FDA, EMA, ICH guidelines, etc.). Lead regulatory interactions with global health authorities, including...: Expertise in global CMC regulatory requirements and best practices. Strong understanding of drug development processes (FDA/EMA...
data during regulatory audits (FDA, EMA, Anvisa, etc) and internal audits. Coordinate quality system elements, training...
deliverables comply with regulatory guidelines (FDA, EMA, ICH, etc.) and company SOPs. Contribute to the preparation of regulatory...
United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA). This position will report to the... of regulatory submissions including Investigational New Drug (IND) and New Drug Applications (NDA) specifically for FDA and EMA...
inspections, and PV audits Working knowledge and understanding of global regulations for safety and PV including FDA, EMA...
In-depth understanding of regulatory requirements and guidelines including FDA regulations, EMA guidelines and ICH standards..., 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter...
/GRAPH. Strong understanding of clinical trial data structures, CDISC standards, and regulatory requirements (e.g., FDA, EMA...
-oriented environment Ability to problem solve and be proactive Experience with electronic medical record systems, EMA...
global product release within the quality management system adhering to FDA, EMA, MHRA, TGA and other ROW Regulatory agency...
. Experience in writing technical drafts for patent filings, IND (US-FDA) or CTA (EMA) filings are desirable. Johnson & Johnson...