Development Center of Excellence for Biologics within the global Lundbeck CMC organization. Since integrating into Lundbeck... in chromatography, filtration, and analytical techniques used in downstream processing. Ensure adherence to FDA, EMA, ICH guidelines...
-functionally with Process Development, MS&T, Quality, and Engineering to ensure smooth transfer and scale-up of processes...'s degree in engineering, Life Sciences, Business Administration, Allied Health or related field Minimum Seven (7) years...
to DEA regulations and other global controlled substance requirements (e.g., Health Canada, EMA, ANVISA). Develop, implement...The Manager, Global Product Quality – Controlled Substances is responsible for ensuring that all activities related...
lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health... with US FDA, EMA, PPTA IQPP standards, CLIA/COLA, and state regulations. Maintain audit and inspection readiness...
collaborations with relevant line functions and with minimal supervision. Responsible for the global regulatory evaluation of CMC... teams. Participate in global regulatory interactions with health authorities, with supervision Facilitate document review...
, and engineering execution in accordance with good documentation practices, including but not limited to executed batch records, master..., Global and Regulatory requirements. Keep abreast of industry developments, forthcoming regulations, guidance, best practices...
generation, and when necessary, the re-engineering of Eisai “Best Practices†related to global submission management and dossier.... If this is your profile, we want to hear from you. The Associate Director of Global Submission Management (GSM) is responsible for leading...