Conduct analytical method development, validation, and routine testing for R&D and stability samples. Perform instrument-based analysis using LCMS, HPLC, GC, NMR, IR, and UV spectrophotometers. Handle method transfer, troubleshooting, and compliance documentation. Prepare protocols, validation reports, and ensure adherence to regulatory standards. Work closely with formulation and process R&D teams to support project timelines. Ensure integrity and accuracy of analytical data and maintain electronic records. Participate in OOS/OOT investigations and continuous quality improvements. Train analysts and support team development in latest analytical technologies.
Roles and Responsibilities Hands-on experience in scale-up, troubleshooting, and debottlenecking of the process and equipment to enhance productivity. Experience in preparing Tech-pack documents for technology transfer from Lab scale -commercialization. Proficient in engineering calculations, equipment mapping, such as material balances, power consumption, and utility requirements. Knowledge in safety studies, including HIRA, HAZOP, and other Process Hazard Analysis
Qualification: MSc in Analytical / Organic Chemistry Pharmacy Life Science Role Summary: Seeking detail-oriented and motivated regulatory compliance specialists to manage and coordinate regulatory activities related to API filings across multiple regions. Responsibilities include preparing, reviewing, and submitting high-quality regulatory documents to ensure global compliance. Key Responsibilities: Prepare, compile, and submit DMFs, ASMFs, and API regulatory dossiers to global authorities. Ensure timely updates, maintenance, and life cycle management of submissions. Monitor global regulatory changes and communicate to internal teams. Handle customer queries, letters of access, and technical data packages. Maintain database and tracking systems for submissions and commitments. Support regulatory and customer audits across all sites. Key Skills & Competencies: Passion to make a difference combined with : Strong analytical and strategic thinking. High attention to detail and ability to manage multiple projects/filings. Excellent written and verbal communication. Experience with Electronic Submission System (eCTD). Knowledge of pharmaceutical standards (USP, EU, JP). Understanding of documentation and filing requirements (US-FDA, EDQM, ANVISA, PMDA, etc.). Familiarity with ICH Q7, M7, Q11, Q12 guidelines.
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