or equivalent in a Medical Device or FDA Regulated industry. Knowledge of fundamental cGMP concepts and FDA/EMA regulations, QSR...
compliance with regulatory standards, including FDA, EMA, and ICH guidelines. Monitor trial progress and ensure high-quality...), and Biologics License Applications (BLA). Serve as the primary medical liaison with regulatory agencies, including the FDA, EMA...
manufacturing facilities: The Harmans/BWI-1 EMA and FDA approved facility, at approximately 200,000 sq. ft., houses 10 CGMP...
to other staff members. Scan appropriate documents into EMA. Verify insurance benefits and eligibility. Collect outstanding...
Location: 1035 Outer Park Dr, Springfield, Illinois, 62704-4462 Agency Contact: EMA[email protected] Posting Group: Fiscal...
. Ensure compliance with all relevant regulatory requirements, including FDA, EMA, and other global regulatory bodies...
, and briefing packages for global regulatory agencies such as the FDA, EMA, etc. Cross-Functional Collaboration: Partner...
related items and eCRT package including aCRF, define.XML, cSDRG, ADRG and ARM for the regulatory submission to FDA/EMA/PMDA...
within a GMP regulated manufacturing environment (FDA, EMA, MHRA), Some experience in biologics and/or gene therapy...
and deliverables are in compliance with FDA, EMA and local regulations and guidance, ICH guidelines, Ultragenyx' policies, SOP... of projects. Ensure activities and deliverables are in compliance with FDA, EMA and local regulations and guidance...