• Responsible to prepare and review of dossier as per CTD / ACTD / Country specific guidelines • Responsible for dossier compilation and query response • Co-ordination with Cross Functional Team and Business Partners • To prepare and review all technical documents (SPEC, BMR, MFR, Validation reports etc) • Proficiency in literature search for products at various stage of R&D. • Ability to conduct secondary research and acquire information from internet sources, journals, public databases, etc. • Experienced and good hand-on drafting Clinical & non-clinical overview/summary. • Required knowledge of toxicity studies, BA-BE studies and clinical trials. • Working on regulatory agencies regarding pre-submission strategies, potential regulatory pathways. • Review of documents to ensure there are no gaps • Maintains the highest level of submission standards. • Maintains familiarity with evolving and/or new regulatory e-submission requirements • Familiarization with evolving guidance of Row markets