across multiple therapeutic areas. Knowledge of regulatory requirements (FDA, EMA, ICH-GCP) and experience navigating complex...
/pharmaceutical industry Experience of regulatory submission with FDA or PMDA Experience of regulatory submission with EMA...
/pharmaceutical industry Experience of regulatory submission with FDA or PMDA Experience of regulatory submission with EMA...
/ medical dermatology, 3-5 days per week Newly built, fully equipped clinic with EMA / EMR and modern exam rooms 30-40...
understanding of the importance of and basic requirements of Regulatory agencies such as the FDA and EMA, particularly in the area...
industry, with a strong focus on API manufacturing and external supply. In-depth knowledge of cGMP regulations (FDA, EMA, HPRA...
through development, database lock, and reporting/submission. Deep understanding of ICH-GCP, FDA, EMA, and other global...
of cleaning processes. Ensure compliance with regulatory guidelines (FDA, EMA, cGMP, ICH) and internal SOPs. Participate... maintenance, and responding to compliance requirements. Strong knowledge of cGMP, FDA, EMA, and ICH cleaning validation...
, and FDA or EMA guidance. Strong analytical, organizational, and problem-solving skills with high attention to detail...
remediation and continuous improvement initiatives. Maintain current knowledge of evolving regulatory requirements (FDA, EMA... or demonstrated proficiency with AI-enabled tools preferred. Knowledge, Skills, Abilities Knowledge Strong knowledge of FDA, EMA...