Title:  Manager-Regulatory & Business Continuity - US Market

Job Summary
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.
Area Of Responsibility
1. New submissions:
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.
2. Approval :
Review & prepare response to deficiency enabling approval of products filed to regulatory agency.
3. Lifecycle management for drug formulations:
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
4. Regulatory compliance:
a. eCTD compilation
b. Ensure reposition of comprehensive product information into central repository
C. Review regulatory filing impact of variations, change controls, etc.