Regulatory Affairs
Posted on :
05-03-2024
Employer Active
1 Vacancy
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Monthly Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
05-03-2024
Job Description
Req ID : 2593460
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 Inprocess & 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.
Employment Type
Full Time
Company Industry
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
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