Lead API Regulartory Affairs Team for Regulartory Affairs activities of company.

• Author high-quality CMC documentation and formulate and lead global CMC regulatory strategy for development projects or marketed products. • Contribute, review and oversee formulation of CMC templates/procedures. • Manage and lead cross function team positioned at different geographical regions.• Monitor the quality of work produced by the team and support quality improvement initiatives as appropriate.• As early as possible, identify the required documentation and any… Show more • Author high-quality CMC documentation and formulate and lead global CMC regulatory strategy for development projects or marketed products. • Contribute, review and oversee formulation of CMC templates/procedures. • Manage and lead cross function team positioned at different geographical regions.• Monitor the quality of work produced by the team and support quality improvement initiatives as appropriate.• As early as possible, identify the required documentation and any content, quality and/or timeliness issues with them for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines. Show less

• Conducting periodic regulatory compliance audits to ensure regulatory compliance.• Provide regulatory evaluation and providing on time and of high quality advice (e.g. change controls for development or marketed drug substance).• As early as possible, identify the required documentation and any content, quality and/or timeliness issues with them for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines.• Managing… Show more • Conducting periodic regulatory compliance audits to ensure regulatory compliance.• Provide regulatory evaluation and providing on time and of high quality advice (e.g. change controls for development or marketed drug substance).• As early as possible, identify the required documentation and any content, quality and/or timeliness issues with them for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines.• Managing contract manufacturing locations (~13) (external supply organization) for regulatory submission.• Managing regulatory audits as site regulatory in-charge from agencies like US FDA, TGA, Japan, Korea and Europe. Show less

I won Ranbaxy Team Appericiate award in year 2007

• Conducting periodic regulatory compliance audits to ensure regulatory compliance.• Provide regulatory evaluation and providing on time and of high quality advice (e.g. change controls for development or marketed drug substance).• As early as possible, identify the required documentation and any content, quality and/or timeliness issues with them for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines.

• Conducting periodic regulatory compliance audits to ensure regulatory compliance.• Provide regulatory evaluation and providing on time and of high quality advice (e.g. change controls for development or marketed drug substance).• As early as possible, identify the required documentation and any content, quality and/or timeliness issues with them for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines.