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 should be proactive in identifying authoring issues, coordinating with stakeholders for technical support, and contributing to regulatory strategy and critical issue identification. Desired skills for this role include good technical knowledge, review skills, ability to try new approaches when faced with challenges, and a positive analytical and learning attitude. You will also be responsible for attending to e-publishing requirements throughout the project lifecycle and ensuring timely delivery of approved technical source documents in accordance with project timelines.,

Posted 3 weeks ago

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