Director Regulatory CMC
Practices (GMP), US and EU drug and biologic regulations and guidelines including ICH, FDA and EMA guidelines...
Practices (GMP), US and EU drug and biologic regulations and guidelines including ICH, FDA and EMA guidelines...
Entertainment Core Metadata) and MMC (Media Manifest Core), and delivery of availability metadata using EMA Avails - Demonstrated...
facilities: The Harmans/BWI-1 EMA and FDA approved facility, at approximately 200,000 sq. ft., houses 10 CGMP manufacturing...
of FDA, EMA, MHRA and ICH GCP guidelines. Attention to detail, strive to generate high-quality work, and sense of passion...
. · Develops and maintains a system for tracking and monitoring deadlines re: responses to motions, orders, EMA reports...
standards (e.g., FDA, EMA) and healthcare laws Excellent leadership, communication, and interpersonal skills Additional...
regulatory requirements and industry mentorship (esp. FDA, EMA, ICH, ISPE). Audit experienced is preferred....
; preferred experiences in oncology an autoimmune therapeutic area Extensive knowledge in FDA, EMA and ICH guidance/guidelines...
Validation. · In-depth knowledge of GxP requirements and regulatory guidelines (e.g., FDA, EMA). · Strong understanding...
documentation and activities comply with FDA, EMA, and other relevant regulatory standards (e.g., 21 CFR Part 11, GxP). Conduct...