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

Shilpa Medicare

2 - 7 years

2 - 7 Lacs

Hyderabad

Posted:1 hour ago| Platform:

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Skills Required

Regulatory Affairs eCTD OSD customer filings Europe Europe Market authority deficiencies US Market RA USFDA Canada pharmacopoeia Anda submissions QMS Formulation Dossier CMC solid orals Injectables Customer Queries

Work Mode

Work from Office

Job Type

Full Time

Job Description

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.
Evaluation of regulatory authority deficiencies and preparation of action plan accordingly. Also follow up of response documents with concern stake holders.
Evaluation and approval of QMS documents, wherever applicable.
To update cross functional teams for different regulatory compliance & requirements.
Responsible for outlining requirements for labelling, storage and packaging.
Review of product development report and QBD concepts.
Updating product approval package to plant team.

Preferred candidate profile

Should Have Formulation Regulatory Affairs Relevant Experience in US/EU/Canada

Perks and benefits

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