Prajakta Sukale
Analyst - Global Regulatory Affairs and Quality @Ashland
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WORK HISTORY
Analyst - Global Regulatory Affairs and Quality @Ashland
Mumbai, IN
Managing and responding to quality/regulatory queries, including compliance requests- Collecting, evaluating, and compiling regulatory information to address both standard and non-standard customer queries- Collaborating with internal teams to develop regulatory statements in line with global compliance requirements (NDMA, TGA, CHP)- Preparing and finalizing regulatory standard documents to align with market needs- Driving continuous improvement initiatives to enhance customer satisfaction- Supporting high-quality customer experience initiatives, globally.Additionally, I contribute to business unit success by- Monitoring regulatory trends to provide strategic insights for business development- Developing and optimizing regulatory technical packages for Sales and Business Development teams- Acting as a liaison between QA/RA teams to support global regulatory processes- Handling regulatory compliance for food & pharma excipients and active pharmaceutical ingredients (APIs)- Reviewing and compiling both technical and non-technical regulatory data for compliance applications- Establishing standard regulatory procedures and publishing best practice guidelines.
EDUCATION
KJ Somaiya college of Science and Commerce
Bachelor's degree, Chemistry
KJ Somaiya college of Science and Commerce
Master's degree, Organic Chemistry
ABOUT PRAJAKTA SUKALE
Analyst - Regulatory Affairs and Quality at Ashland
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