Posted:1 day ago|
Platform:
Hybrid
Full Time
Regulatory submission of new products, variations, response to queries, Life cycle management for US and OAM region through preparation of quality dossiers enabling timely approvals.
a. Review & prepare CMC (Chemistry, Manufacturing and Controls) dossiers for fresh submissions.
b. Review documents (Development report, scale up report, specification, stability protocol, analytical validation), etc. Before initiation of Exhibit batches for adequacy.
a. Prepare and review variation , Annual notification and labelling approval for US and OAM
b. Review of change control and file variation as per country requirement
a. eCTD compilation
b. Ensure reposition of comprehensive product information into central repository
C. Review regulatory filing impact of variations, change controls, etc
Sun Pharma
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