This position is responsible for developing a solution-based strategy from regulatory and scientific perspectives, planning, reviewing, and submitting all targeted original applications (including complex injectables, drug-device combinations such as PFS/Bags, synthetic peptides, microspheres, etc.), life-cycle management supplements, annual reports, alternate sources, sites, process improvements, amendments, and deficiencies with a focus on quality submission and speed.
Review and submission of the new NDA (505b2) and ANDA filings and support the development of the regulatory strategy for new SI products.
People manager to execute all the regulatory activities pertaining to reg. strategy, periodic input to R&D for current and future products.
Review the deficiency response and submit it within the stipulated timeframe.
Review and submission of LCM Injectables products (site transfers to Indore).