Regulatory Consultant Metina PharmConsulting

8.0 - 12.0 years

0 Lacs

navi mumbai, maharashtra

On-site

The person will be responsible for project specific regulatory consulting services at the firm. You will have complete ownership of all regulatory projects, including dossier writing, submissions, approval tracking, and query resolution across Developed and Emerging markets. Your role will involve ensuring regulatory compliance, accuracy, timely completion, version control, and adherence to internal SOPs. Additionally, you will provide strategic input to the Management and Partners on regulatory projects. It is essential to keep abreast of new developments in regulations across all critical health authorities. The ideal candidate should have formal regulatory affairs experience for a minimum...

Posted 2 weeks ago

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Regulatory Affairs US- Executive / Sr Executive Unichem Laboratories Limited

5.0 - 11.0 years

0 Lacs

maharashtra

On-site

You should have a minimum of 5-11 years of experience in authoring high-quality CMC documentation for US FDA submissions, including Original ANDA/Deficiency responses/Post approval supplements/Annual reports. Your responsibilities will include identifying required documentation for US regulatory submissions, ensuring technical congruency and regulatory compliance, reviewing and identifying content issues with source documents, and keeping knowledge up to date with regulatory guidelines. You must have a B. Pharm/M. Pharm qualification and possess hands-on experience with eCTD software, as well as a strong understanding of CTD/eCTD requirements for submission of dossiers. Additionally, you sho...

Posted 2 months ago

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