We are looking for young and enthusiastic minds, who will be responsible for the following roles -
1. Preparation and compilation of CTD and ACTD dossiers for Vietnam, Myanmar and ROW market
2. Review of Process Validation, Analytical Method Validation, Product Development Records, BMR, BPR, Stability data, Certificate of Analysis etc. required for dossiers
3. Co-ordinate with departments such as Manufacturing, Product Development, QA/QC, R&D;, Legal, Purchase etc. to ensure availability of documents and samples for submission.
4. To check & review Art-works, Labels, and Pack-inserts
5. Response of queries and other requirements as required by respective regulatory authorities in a stipulated time frame
Job Type: Full-time
Job Type: Full time
Pay: ₹180,000.00 - ₹360,000.00 per year
Ability to commute/relocate:
- Hiranandani Estate, Thane, Maharashtra: Reliably commute or planning to relocate before starting work (Required)
Education:
- Bachelor's (Preferred)
Experience:
- Dossier Preparation of Tablets: 1 year (Required)