, GAMP 5, GDPR, FDA/EMA guidelines). Manage and mentor a team of product managers, business analysts, and technical leads...
. Regulatory & Audit Support: Serve as a technical SME during regulatory inspections (FDA, EMA) and maintain an elite knowledge...
per FDA, EMA, and ICH guidelines with 21 CFR Part 11 compliance. Develop calibration procedures and establish intervals based...
& Technical Duties Utilize EMA (Electronic Medical Assistant), a dermatology-specific EMR system Enter and initiate patient...
and maintain GxP-compliant SOPs, policies, controls, and audit trails aligned to global expectations (GMP, ICH, FDA, EMA... work in a matrix environment Strong command of regulatory frameworks (GMP, ICH, FDA, EMA), product lifecycle and labelling...
, or monitoring oversight. Strong understanding of ICH-GCP, FDA/EMA regulations, and global clinical trial guidelines. Demonstrated...
, EMA, Health Canada, PMDA) Lead preparation and authorship of CMC sections (Module 2.3, 3) for: INDs/CTAs/Amendments Lead... strategies. Familiarity with global regulatory frameworks (FDA, EMA, ICH guidelines) Proven ability to operate effectively...
that meet both regulatory and company requirements. Maintains expertise on various regulations (FDA, EMA, ICH, etc.) Provides...
Emergency Communications, EMA operations, and PSC technology initiative. Supports budget preparation and ensures alignment...
. Deep knowledge of FDA, EMA, and global GMP regulations, inspection expectations, and industry best practices related...