Key responsibilities of DRA Executive
1 Preparing documents for obtaining marketing permission, COPPs, FSCs and other certificate as required from the FDCA.
2 Compilation & review of documents for dossier submissions.
3 Addressing queries received on dossiers submitted for approvals.
4 Supervising the preparation & submission of registration samples in interaction with the production and QC department.
5 Filing of the office copies of dossiers, certificates and other documents filed with regulatory authorities.
6 Preparation of PDL upon receipt of the regulatory approval.
Salary: INR Salary is no bar for right Candidates
Industry: Pharma / Biotech / Clinical Research
Functional Area: Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology
Role Category: Drug Regulatory Affairs/Documentation
Role: Regulatory Affairs Manager
Employment Type: Permanent Job, Full Time