Officer/Executive RA - API

Role & responsibilities

1. Co-ordination with CMC team at site for documents required to compile the documents

2. Review of process related and quality related documents

3. Review of guidelines of various countries for AMVs and share with site. Check whether the documents received from site are in line with the requirements.

4. Knowledge to review the documents required to handle the impurity section of DMF.

5. Preparation DMF in CTD format. Submission in eCTD format.

6. Handling the queries raised by the agencies.

7. Preparation of revision/Renewals/Annual updates

Preferred candidate profile

Desired Skills (MS Office / SAP/ etc.): MS office/ computer operation expert

Desired Qualification: MSc. organic/Analytical