Address 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).
Education: M.Pharm
Experience : minimum 10 years relevant experiene
