Manager - 1

4 weeks ago

Vadodara India SUN PHARMA Full time

Job Description

Job Description

- Review all data and documents related to product registrations for various health authorities.
- Compile registration dossiers for submission to various health authorities like US-FDA, Health Canada, Europe, Australia/New Zealand, Japan and Israel.
- Prepare responses to deficiency letters received from various agencies.
- Maintain life-cycle / post approval changes for drug product registration dossiers.
- Provide regulatory support to cross functional departments.
- Prepare and submit scientific advice to various health authorities.
- eCTD compilation, verification and submission through electronic gateway
- Review, preparation and submission of annual reports to US FDA
- Review, preparation and submission of post approval supplements to US FDA
- Reviewing of the plant change control and established the variation strategy for submission
- Review of query response prepared and compiled by regulatory associates
- Review of all the documents received from stake holder for dossier compilation , Query response and Life cycle management
- Allocation of projects to regulatory associate & manage the team for all the regulatory submission activities

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