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 positive 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 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 Job Type Full-time Education Bachelor s Preferred Experience out of total 1 year Preferred Work Location In person