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

　　Be the change you wish to see. Come join us! We want the best and brightest people at Endo to help us achieve our mission to develop life-enhancing products through focused execution. Our 3,000+ global team members are united by the important role that we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward.

　　All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.