- Responsible for preparation & compilation of the dossiers in CTD/eCTD/ACTD and other formats as required for submission to different regulatory authorities.
- Review the documents i.e. Specifications, Batch Records, STP, Stability Protocol, Dissolution protocols & DMF documents etc.
- Preparation of pharmaceutical/quality part (all forms) of registration dossiers & variations/amendments/annual reports as applicable documents in CTD and eCTD format.
- Preparation of query response for submitted applications received from various regulatory authorities.
- Responsible for review of change controls and checking for regulatory compliance for all documents.
- Exposure of Dossier compilation for ACTD & CTD is mandatory.
- Coordination with the external stakeholders for the preparation of the regulatory documents.
- To be responsible for the Life cycle management of assigned products.
- Should have experience for Life cycle management and license Maintenance.
- Should have good knowledge for recent guidelines, websites and trends of Europe, Africa, Mexico, LATAM region, Chile, Costa-Rica, Peru, Panama, Asian, CIS market.Role & responsibilities
Desired Candidate Profile:
- Candidate must have valuable knowledge of working in Europe, Africa, Mexico, LATAM region, Chile, Costa-Rica, Peru, Panama, Asian, CIS market.