- Preparation & compilation of DMF/ASMF/CEP in CTD/eCTD format
- Lifecycle management, change controls & regulatory submissions
- Handling regulatory authority & customer queries
- Preparation of amendment reports, annual updates & technical packages
- Coordination with R&D;, QA, QC, Production & Marketing teams
- Review of validation documents, BMR & regulatory documentation
- Regular plant visits for documentation, audits & CAPA follow-up
Required Skills
- Solid knowledge of API Regulatory Affairs
- Experience in DMF, CEP, CTD, eCTD submissions
- Knowledge of EDQM, Europe & ROW market regulations
- Good communication & documentation skills
- Ability to manage timelines & multiple submissions simultaneously
Mandatory Requirements
- Experience in API Regulatory Affairs in Pharma company only