Regulatory Affairs ( API )- Sr. Executive

2 - 6 years

3 - 7 Lacs

Dera Bassi

Posted:2 months ago| Platform: Naukri logo

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Skills Required

USFDA Regulatory Affairs CMC Dmf CTD

Work Mode

Work from Office

Job Type

Full Time

Job Description

Oversee the preparation, review, and submission of regulatory filings, including DMFs, ANDAs CTD submissions, and other relevant documentation. Document review Preparation and submission of DMF to various countries. Review & verification of BPCRs , PVP/PVR and method validation reports. Regularly updating and maintaining regulatory work sheets for monthly management review. Review and compiling vendor Qualification Documents and ROS etc. Review and compiling of CMC documents. Gathering and reviewing documents received from QA and other departments. Compilation of technical Data Packages, Quality Overall Summary & Open Part DMFs. Preparing US DMFs for USFDA, ASMF, CEP etc. Preparing Customer query response to AP/OP DMfs & TDPs raised by various customers. Preparing Applicant Part/ Open Part DMFs to various Customers. Preparation of LOAs LOEs, others declarations & commitment based on customers.

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Saurav Chemicals (SCL)
Saurav Chemicals (SCL)

Chemicals

Pune

200 Employees

9 Jobs

    Key People

  • Saurav Jain

    CEO
  • Aditi Mehta

    Chief Operating Officer

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