Posted:1 week ago|
Platform:
On-site
Full Time
We're hiring!! Looking for an energetic Regulatory Affairs professionals join our team in Gurgaon.
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.
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.
SUN PHARMA
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