and in compliance with all applicable federal, state, and company regulations (OSHA, EPA, FDA, EMA etc.). Responsible for the...
Lead interactions with FDA (CDER/CBER/CDRH as applicable), EMA, and other global health authorities, including Type A/B/C... new and evolving FDA/EMA guidances, PDUFA commitments, and international regulatory developments;assess impact...
Parts 210/211, ICH guidelines, EMA requirements). Exceptional organizational, communication, and stakeholder management...
with the EMA review process concluded positively in September 2023. It is an exciting time in the company’s development...
’s I-270 Technology Corridor, top universities, and government agencies. The Harmans/BWI-1 EMA and FDA approved facility...
and influence including explaining complex quantitative issues in simple terms Solid understanding of Regulatory (FDA/EMA...
Technology Corridor, top universities, and government agencies. The Harmans/BWI-1 EMA and FDA approved facility...
, EMA, and other regulatory requirements. Leadership Skills: Strong leadership and people management skills, with the...
while still meeting set deadlines Good knowledge of existing guidelines dealing with cleaning and disinfection/CIP COP (EMA;FDA...
compliance with FDA, EMA, and cGMP regulations. Responsibilities: Lead validation lifecycle activities including Design... Experience with FDA, EMA, 21 CFR Part 11, and GAMP 5 guidelines. Excellent technical writing and documentation skills...