Executive Regulatory (xEVMPD)-With Top Pharma MNC Co, Mumbai.

Job Specification:

1. Create, Review, and carry out quality control (QC) checking of Company xEVMPD records for submission to the European Medicines Agency (EMA) in line with requirements of Article 57(2).

2. Requires extensive use of Company xEVMPD records submissions application.

3. Requires extensive reference to Company product registration data contained in reports and stored in Company RIM system.

4. Requires extensive reference to SmPCs and associated regulatory documentation stored within Company DMS.

5. Collaborate with Company RA personnel to acquire missing xEVMPD submissions data or to obtain clarifications required to complete xEVMPD record submissions.

Candidate Profile:

1. Maintain working knowledge of Article 57(2) requirements and EMA guidance documentation. 2. Experience of using an xEVMPD submissions application.
3. Experience of using RIM systems.
4. Experience of accessing and retrieving documentation from electronic document management systems.