management. Strong working knowledge of applicable FDA, EMA, ICH, pharmacopeial, and global cGMP expectations for biologics...
of Current Good Manufacturing Practices (cGMP) and applicable regulatory guidelines (FDA, EMA, etc.) in an aseptic environment...
during regulatory inspections (FDA, EMA, and other health authorities) Aseptic & Microbial Control by Design Serve as the Global.... Demonstrated experience authoring and defending technical positions during regulatory inspections (FDA PAI/GMP, EMA, PMDA...
and audits (FDA, EMA, internal, or client audits) Strong technical writing skills with attention to detail and data integrity...
with biopsies, excisions, sutures, cryotherapy, or cosmetic procedures. Experience using an EMR such as EMA, ModMed, NextGen...
, 820, ISO 13485, ISO 14971, EMA, PDA, ICH, etc.) Knowledge of Design Controls and experience with change management...
, IBs, and health authority briefing materials, supporting direct interactions with global regulatory bodies (FDA, EMA...
Serve as a key technical resource during regulatory inspections (FDA, EMA, PMDA, and others), providing expert testimony...
-to-date knowledge of regulatory requirements (ICH Q2(R2), ICH Q10, FDA, EMA guidelines) Collaborate with internal and external teams...
organization Strong working knowledge of EMA, FDA, and/or USDA regulations and guidelines Demonstrated commitment to Diversity...