executive - (f&d).

- Review of plant documents like batch records, process validation protocols and reports etc.
- Review the documents prepared by R&D like PDR, analytical method validation/verification
protocols and reports, MMF etc.
- Assist the formulation development and analytical development team during development of
product.
- Review of API DMF and coordination for the documents.
- Preparation and review of labelling documents like SPC and PI.
- Co-ordinate in preparing the artwork and approval of the labelling text.
- Compilation and submission of post approval supplements, annual report and PADER for US
market
- Compilation and submission of variation for Europe and ROW markets.
- Provide the regulatory inputs during development of drug product.
- Coordinate with Regulatory Agencies.
- Publishing the dossier/variations/post approval supplements/annual report in eCTD manager.
- Life cycle management of drug products and support to the plant for commercial supply.
- Coordinate with different clients and affiliates to timely submission of dossier/response.
- Coordinate with different departments (QA, QC, Production and R&D) for availability of