Walk In For Regulatory Affairs - US/EU/CA -Executive/Sr Executive Shilpa Medicare

2.0 - 7.0 years

2 - 7 Lacs

Hyderabad

Work from Office

Role & responsibilities Handling of pre and post approval regulatory activities of US/EU/CA submissions. Review of developmental documents for regulatory submission. Good knowledge of handling CMC documentation for Dossier submission Compilation and Submission of Annual reports and Supplements. Having the experience of solid orals and injectables. Preparation of Sterility Assurance Package for injectable Dossiers. Preparation of Pre-IND/scientific advice meeting packages Drafting, compiling & eCTD publishing of dossiers for regulatory filings. Review of specifications and test procedure as per pharmacopoeia requirements. Providing regulatory support for customer filings and customer queries....

Posted 3 months ago

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Regulatory Affairs - US/EU/CA -Executive/Sr Executive Shilpa Medicare