1.Preparation of CTD/eCTD dossiers for various regulatory agencies.
2.Review of SOPs related to Regulatory submissions.
3.Co-ordination with various departments like production, QA, QC, R&D for Regulatory documents.
4.Review of specifications, STP and COA to make inline with USP, Ph.Eur.
5.Review of protocol and report as per Regulatory aspects (eg. Stability, Analytical method validation etc.)
6.Review of Drug master File (DMF)
7.Preparation of database for various regulatory guidelines.
8.Maintaining matrix for different products as per the requirements of different, Regulatory agencies and providing training on Regulatory requirements.
9.Preparation of documents for NOC, Test license, Import license and Manufacturing licenses.
Candidates having injectable / Formulation background are highly preferred. Candidates must be self motivated with excellent written and verbal communication skills. Good interpersonal and project management skills are critical for this position.