• Cross Functional Collaboration : Experience in collaborating with Internal teams and external stake holders • To attend client telecom and accordinly need to be respond the queries. • Litertaure and other search to understand the regulatory Requirement from USFDA guidelines • To review DMF, PDR, BPR, BMR, In process sampling, specification, stability, packing and excipients • To prepare the ANDA Submission documents considering eCTD. • Provide response to regulatory agencies. • Regulatory submission • Experience in US market is mandatory
