This position will entail the following responsibilities: filing US Drug Master Files (USDMFs), reviewing outsourced Drug Master Files (DMFs), managing product lifecycle, submitting post-approval supplements, addressing regulatory deficiencies, and evaluating change control proposals.

　　Preparation of Drug master files for submissions to USFDA as per Regulatory guidance.

　　Compilation of responses for USFDA deficiencies for in-house DMFs.

　　Proactive review from perspective of evolving regulatory requirements / expectations/prior experience, with an assurance to limit and/or avoid any deficiencies for drug substance (i.e. In-house and /or Outsourced Type II DMF), so as to get referencing ANDA, approved within timeline defined in GDUFA III.

　　Review of documents for the designation of KSM, vendor compliance check w.r.t regulatory inspection, Specs of KSM, ROS of API, Control strategy Intermediates and API as per current regulatory requirements.

　　To coordinate with SCM for all necessary documents from KSM supplier as per regulatory requirements.

　　To coordinate with PD and AR&D during development to ensure the data as per the regulatory requirements.

　　Review of product development report, Analytical method validation documents, BPRs and finalized quality documents required for the DMF submission.

　　Compilation of Annual Reports, Quality Amendments etc.

　　Regulatory database management and maintaining the regulatory status.

　　For outsourced APIs, review of applicant part (AP)/tech pack as per current expectations of FDA.

　　Review of the DS part in the ANDA, and CRLs/IR/ECDs responses prepared for its completeness.

　　Handling change control and Change notifications and decision on post approval change category in line with the regulatory guidance for in-house and outsourced API.

　　Provide regulatory support through product life cycle.

　　Monitor pertinent FDA web sites for new guidance’s that may impact current and future ANDAs and external projects.

　　Education/Qualification: M.Sc. Chemistry/M. Pharm (5-10 Years Experience in API-RA

　　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.