· Designing of preclinical studies as per the regulatory requirements to support the clinical bridging.
· Preparation and review of preclinical study synopsis, study protocol and reports.
· Preparation and Review of clinical development strategies.
· Preparation and Review of clinical study synopsis.
· Preparation and review of regulatory submission documents like Scientific advice, Pre IND package, controlled correspondence.
· Preparation and review of Initial pediatric study plans (iPSP).
· Identification of unmet needs through active stakeholder interactions and actively contributes in the new product ideation and development of differentiated products.
· Preparation of slides on medical rationale for differentiated products.
· Preparation and Review of non-clinical overviews, Clinical overviews, Investigator's Brochure (IB).
· Preparation and review of clinical documents for Marketing Authorization Application
· (MAA).
· Preparation and review of presentation, executive summary for SEC meetings (CDSCO).
· Preparation and review of manuscripts for paper publication in peer reviewed journals.
· Providing literature support for regulatory queries and regulatory literature search for various drug molecules.
· Supporting clinical research aspects of products in development and supporting other miscellaneous activities, where medical reviewer intervention is needed.
