Experience
2 - 6 yrs
Job Location
India
Vacancy
1
Designation
Regulatory Affairs
Job Type
Not specified
Job Description
Job Responsibilities:
- Preparation, review & submission of Post approval changes supplements.
- Responsible for review of OOS, OOT, Change control, deviation As per Regulatory guidelines.
- Monitoring of Post approval commitments for commercial batches.
- Preparation, review & submission of queries.
- Review of stability data of Exhibit batches & all the filling documents required for ANDA submission.
- Review of Finished product, In-process & API analytical documents for regulatory filing.
- Managing & responsible for review of Exhibit Process monitoring protocol & report for submission purpose.
- Maintain a regulatory database on site.
- Monitoring & compliance of Post approval commitments for commercial batches.