, validation, and/or technology transfer. Experience authoring technical documents supporting regulatory filings (FDA, EMA, JNDA...
those of the FDA, EMA, and other relevant authorities. Ability to collect, process, and analyze data using established methods...
FDA, EMA, ICH, and ISO. · As a member of the Quality Leadership Team and key advisor on global compliance policies...
differences from manned aircraft. Experience with EMA or EHA control surface actuators. Secret clearance eligible...
. Knowledge of Athena, Epic, EMA EMR systems a plus. Must have a valid driver's license and be willing and able to drive...
, biotechnology, chemical, industrial, or other highly regulated operations Knowledge of cGMP, cGLP, OSHA, EMA, FDA, or similar...
audits (FDA, EMA, Anvisa, etc) and internal audits. Manage and oversee the interrelated function activities including design...
of FDA, EMA, and ICH guidance relevant to clinical pharmacology (e.g., ICH M12 on drug interaction studies, ICH M15 on MIDD...
recommendations to functional and site leadership. Conduct regulatory and procedural gap assessments against applicable FDA, EMA... regulations, FDA and EMA expectations, data integrity, good documentation practices, and quality systems;knowledge of ATMP and EU...
or managing direct reports is desirable. Experience in writing technical drafts for patent filings, IND (US-FDA) or CTA (EMA...