
Regulatory Affairs Specialist
3 days ago
Role & responsibilities
- Responsible for Drug Master Filing submissions to various regulatory agencies like USFDA, European Agencies, Brazil, and other semi-regulatory countries.
- Review and submission of Response to queries raised on DMF by USFDA, and other agencies.
- Review and submission of Amendments and revisions of Drug Master Files.
- Review and ensuring the regulatory compliance of CMC information and manufacturing facilities of advanced intermediated through regular visits, which are intended to submit to regulatory markets.
- Evaluation of cost reductions processes in regulatory point of view and submitting to different regulatory agencies.
- Review of OOS, BPR, process validation, and other quality assurance documents required for regulatory submissions.
- Markets Handled: USA, Europe, Canada, Brazil, other ROW etc.
Preferred Candidate
- Candidate must have experience working in Regulatory Affairs in Pharma API Industry.
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