TechGuru, Your pic of cars outside the Amarex o
Post# of 148262
Your pic of cars outside the Amarex office on a Sunday could be filed under:
"Things that make you go hmmmmmm"
Maybe this one is along that same train of thought.
About 1 week ago American Regent posted for the following position:
Regulatory Affairs Submission Analyst II
A Brief Overview
This position will prepare all electronic regulatory submissions to health authorities including FDA, Health Canada, and EU filings.
What you will do
Obtain regulatory documents and initiate eCTD compilation using templates, publishing tools and publishing software.
Coordinate with the assistance of Regulatory CMC team member in the planning, assembly, publishing, and submittal of regulatory submissions in eCTD format for FDA and other regulatory agencies.
Review and dispatch of regulatory submissions to the FDA and global Health Authorities within required timeframes.
Ensure completion of high-quality submissions in eCTD format in compliance with applicable regulations, guidance’s, and Regulatory Operations standards.
Maintain proficiency and expertise with the tools and processes associated with electronic regulatory submissions; Responsible for archival and indexing of regulatory files.
Prepare and maintain Regulatory SOPs, Policies and Procedures regarding electronic submission and requirements.
Note that the overview includes the EU.
Their posting includes this description of the company:
American Regent, Inc., a Daiichi Sankyo Group Company, develops, manufactures, and supplies high quality sterile injectables for healthcare providers, clinics, hospitals and veterinary practices across the United States and Canada.
So they are apparently not currently in the EU. Could they be getting ready to add the EU to their current distribution and supply agreement with CYDY? It is possible, however, that they are preparing to expand distribution of their own products into the EU.
https://americanregent.wd1.myworkdayjobs.com/...I_R-100528