Remote
Full Time
Experienced in documentation (pharma companies) and negotiation. Person should know Documentation, reviewing, complying from the scratch. A person who prepares, controls and authors CMC documentation. CMC : Chemistry manufacturing and control Involved in Drug launch The person should know end to end process. Like involving with R&D team/plant etc. Coordinate and deliver the process seamlessly. License renewal Experienced in getting pre-approval and post- approvals with authorities with different countries. Good prior experience in authorizing dossiers in US, UK market. Or emerging market like Africa. ROW - rest of the world market Proficient/Good working experience in Veeva tool. Should have very good technical understanding of the tool
Lancesoft
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