expertise in regulatory and compliance requirements for microbiological methods and specifications, including ICH, FDA/EMA...
to corporate or enterprise-level quality teams. Ensure compliance with GMP, GLP, FDA, EMA, and other applicable regulatory...
such as Food and Drug Administration (FDA), European Medicines Agency (EMA), and International Council for Harmonisation...
for accuracy, using EMA EMR to document all pertinent elements of a patient exam accurately and thoroughly, and other duties...
Selection, and Approvals and Continuous Improvement. Provides support and interfaces directly/indirectly with the FDA, EMA, MHRA...
. Thorough command of FDA, EMA, MHRA and ICH GCP guidelines. Attention to detail, strive to generate high-quality work...
regulatory landscape (e.g., FDA/EMA) for AI/ML-based evidence. Ensure all analytical workflows comply with GCP, HIPAA, and GDPR...
to clinical development are highly desirable. Understanding of FDA, EMA and ICH regulations and guidelines. Experience working...
for assigned programs, ensuring alignment across US (FDA), EU (EMA), UK (MHRA), Japan (PMDA) and other target markets. Lead the... of contact via regional consultants/services for health authority interactions across multiple regions, including EMA (Scientific...
in Regulatory Affairs (freshers with relevant internships can apply). Basic understanding of regulatory guidelines (FDA, EMA...