Clinical Trial Manager
conduct and in-house operational models Familiarity with ICH/GCP, FDA/EMA guidelines, and regulatory best practices...
conduct and in-house operational models Familiarity with ICH/GCP, FDA/EMA guidelines, and regulatory best practices...
level in your assigned EMA/TGA. Utilizing your strong understanding of all the Ryan White Services, you will know... and procedures are in accordance with the current EMA/TGA HIV Case Management Standards. This position will work with both staff...
members, supporting technical and professional development. Ensure processes meet all regulatory guidelines (FDA, EMA...
compliance with standards with timely regulatory submissions (FDA pre-IND, IND, EMA CTA). Hands on medical monitoring duties...
negotiations. Act as primary or co-lead for interactions with health authorities (e.g., US FDA, EMA, MHRA, PMDA), including..., EMA, MHRA) and achieving positive compliance outcomes. Strong ability to establish partnerships, manage complexity...
range of regulatory inspections (FDA, EMA, MHRA) and facilitating QA relationship with external clients. The position... preparation;Reviewing, and analyzing regulatory inspection data issued by regulatory authorities (e.g. MHRA, EMA, FDA);Manage...
of Spanish and English-speaking consumers referring to AID Atlanta, the Atlanta EMA, and Georgia for Client Services Case...
) in line with regulations Oversee coordination of artwork and EMA linguistic reviews Ensure compliance with Health...
inspections is a plus (FDA, MHRA and EMA);Strong communication skills;Strong quality mindset;Excellent written and verbal...
(e.g., US FDA, EMA, MHRA, PMDA), including drafting inspection responses, preparing submission-related GMP evidence... for organizations facing FDA Warning Letters or Consent Decrees preferred. Background working with agencies such as the US FDA, EMA...