) and development documentation, ensuring scientific rigor and compliance with global regulatory requirements (ICH, FDA, EMA, cGMP...
Journeyman License, NACE CIP 1, 2, 3, EMA (Expediting Management Association) Basic, Advanced, ASNT NDT Level II, III, and ASQ...
Journeyman License, NACE CIP 1, 2, 3, EMA (Expediting Management Association) Basic, Advanced, ASNT NDT Level II, III, and ASQ...
/biotech manufacturing or comparable regulated industry Strong knowledge of cGMP regulations (FDA, EMA, ISO) Experience...
of digital strategy and activation Current service lines: SEO/GEO, Paid Media/Paid Social, Business Insights, Data Science, EMA...
knowledge of cGMP/ICH/FDA/EMA regulations Expertise with analytical test method optimization, validation, and transfer as well...
datasets, narratives, and summaries meet FDA, EMA, and ICH standards for regulatory filings Contribute to key clinical...
required. Experience in post-marketing pharmacovigilance/drug safety. Strong knowledge of: FDA and EMA PV regulations ICH E2...
regulations (ICH, FDA, EMA, MHRA). Proven track record supporting clinical development, regulatory submissions, and post...
assessments)SOPs, deviation investigations, and CAPAs. Ability to support regulatory inspections and audits (FDA, EMA, internal...