Regulatory Affairs Officer

Roles and Responsibilities :

1. Preparation and compilation of CTD and ACTD dossiers for Regulated and Emerging Market. 

2. Review of Process Validation, Analytical Method Validation, Product Development Records, BMR, BPR, Stability data, Certificate of Analysis etc. required for dossiers. 

3. FDA related work- Application of COPP, Legalization of Documents through different embassies, Loan License documentation etc. 

4. Co-ordinate with department such as Manufacturing, Product Development, QA/QC,R&D, Legal, Purchase etc. to ensure availability of documents and samples for submission.

5. To develop, check & review Art-works, Labels, and Pack-inserts.

6. Response of queries, Variation Files and other requirements as required by respective regulatory authorities in a stipulated time frame.