Makarba, Ahmedabad, Gujarat
INR 1.2 - 1.8 Lacs P.A.
On-site
Full Time
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 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 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 Pay: ₹10,000.00 - ₹15,000.00 per month Benefits: Flexible schedule Schedule: Day shift Supplemental Pay: Yearly bonus Work Location: In person
India
INR 1.2 - 1.8 Lacs P.A.
On-site
Full Time
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 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 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 Pay: ₹10,000.00 - ₹15,000.00 per month Benefits: Flexible schedule Schedule: Day shift Supplemental Pay: Yearly bonus Work Location: In person
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