Senior Regulatory Affairs Associate - NY Job at AVK MANAGEMENT SERVICES PVT LTD
Job Purpose:
Prepare, review, evaluate, compile and publish FDA submissions such as Annul Reports and Labeling supplements as needed in eCTD format.
Responsible for development of product labeling, including package inserts, container labels, Medication Guides, for the pending and approved ANDAs.Self-Inspections
- Prepare and submission of Annual Reports as per the Anniversary dates.
- Prepare and submit Labelling supplements for RLD updates for commercial products and amendments for unapproved products
- Structured Product Labelling.
- Updates to CMC and Labelling databases.
- Review of change controls and batch manufacturing/packaging records with the supervision of senior member.
- Responsible for archival of the electronic submission documents in the product specific files.
Regulatory Maintenance
- Assist in the ECTD compilation of ANDAs and other supplements
- Assist in the maintenance of Establishment Registration for all InvaGen Facilities.
Other duties may be assigned as necessary to the roles and responsibilities
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