two manufacturing facilities: The Harmans/BWI-1 EMA and FDA approved facility, at approximately 200,000 sq. ft., houses 10... laboratories; Support regulatory (FDA, EMA) and client audits/inspections of Catalent. Provide quality oversight of process...
Manufacturing Practices (cGMP), Food and Drug Administration (FDA) and other regulatory requirements (EMA, TGA) including audit...
, preferably in a biotech or pharmaceutical manufacturing operation. General understanding of relevant FDA/EMA regulations...
regulatory CMC intelligence activities, provide counsel, training, and interpretation of FDA, EMA, and other health authority... understanding of relevant regulations and guidelines, including ICH, FDA, and EMA guidelines, for the development of small molecule...
requirements and guidelines for document preparation (ICH, FDA, EMA). Proven experience in preparing and editing a wide...
and SOP compliance. Responsible for manufacturing related regulatory compliance (FDA, EMA, IPEC, ISO, etc.), adherence..., and accountability in the area of regulatory compliance (FDA, EMA, IPEC, ISO, etc.) and standard operating procedures Seek out...
/Registered MA strongly preferred. Must be willing to take the National Exam if not. Strongly prefer someone with EMA EHR...
/Registered MA strongly preferred. Must be willing to take the National Exam if not. Strongly prefer someone with EMA EHR...
of cGLP/cGMP and applicable FDA, EMA and ICH guidance preferred. Excellent communication skills, both verbal and written....
to other staff members. Scan appropriate documents into EMA. Verify insurance benefits and eligibility. Collect outstanding...