Sr Executive Officer Regulatory Affairs
Sr Executive Officer Regulatory Affairs
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
- Preparation of New Drug Master files for USA EDQM Europe Australia Japan Canada China Brazil and Rest of World for accuracy as per their individual regulatory requirements.
- Preparation of DMFs Amendments/Updates/Variations for USA EDQM Europe Australia Japan Canada China Brazil and Rest of World for accuracy as per their individual regulatory requirements.
- Preparation of Open parts of Drug Master Files for accuracy as per regulatory requirements.
- Preparation of regulatory deficiencies received from regulatory agencies/customers for accuracy.
- Review of vendor documents for key starting materials/intermediates of API as per regulatory guidelines.
- Review of technology transfer dossiers as per regulatory filings.
- Evaluation of changes (process facility batch size analytical documents etc. and their impact on Regulatory filings.
- Preparation of change notification to customers.
- Review and maintenance of Change control compliance database and follow up with plant and marketing team.
- Review of Sales order.
- Coordination with plant QA QC and production for timely catering to document/samples requirements for regulatory submissions.
- To provide commitments made in regulatory dossiers to QA for their compliance.
- To provide support during all the audits conducted by the customers/regulatory authorities.
- Preparation and review of declarations cover letters letters of access and letters of engagement.
- Responsible for handling of change control.
Required Experience:
Senior IC
Employment Type
Full-Time
