Manager / Sr Manager Regulatory Affairs– US Markets

3 weeks ago

Navi Mumbai Maharashtra India, Maharashtra Umedica Laboratories Private Limited Full time

UMEDICA is a vertically integrated company engaged in the manufacturing and export of a wide range of finished formulations i.e., Tablets, Capsules, Suspensions, Dry Syrups and SVP, at UMEDICA's manufacturing facility, located in Vapi (Gujarat). Facility is accredited by global regulatory agencies like EU, PICs, Local FDA and Inspected by USFDA.UMEDICA was founded in 1983 and has business operations in more than 85 countries including EU, UK, USA, Canada, Australia, Middle East, Central & South American countries, Africa, Asia & CIS countries.We at UMEDICA strive to achieve more through a culture of innovation & continuous improvement.As part of our further expansion and growth plans, we are looking to hire Manager / Sr Manager Regulatory Affairs– US Markets in Regulatory Affairs department.This position is based at our R&D center at Turbhe Navi Mumbai and will report to the Head Regulatory Affairs.The remuneration package will be commensurate with the incumbent’s professional experience and will be in line with market standards.Key Responsibilities:Regulatory Submissions:Lead end-to-end preparation and submission of ANDA and NDA dossiers to the USFDAManage query responses, amendments, and post-approval submissions (PAS, CBE, Annual Reports)Ensure compliance with current USFDA regulations and guidance documentsFDA Interactions:Prepare and submit FDA meeting requests and meeting packages (Type B, C meetings)Participate in and support FDA meetings as the regulatory leadHandle Controlled Correspondence with the FDA for product development and regulatory strategyProduct Expertise:Provide regulatory support for complex formulations, including injectables and liquid dosage formsCollaborate with R&D, QA, QC, and manufacturing teams to ensure regulatory alignment throughout the product lifecycleLeadership & Communication:Lead a team of regulatory professionals, providing guidance, training, and performance managementCommunicate effectively with internal stakeholders and external regulatory bodiesQualifications & Experience:Master’s degree in Pharmacy13–15 years of experience in US Regulatory Affairs with a proven track record in ANDA/NDA submissionsHands-on experience with FDA meetings, Controlled Correspondence, and post-approval changesStrong understanding of injectables, liquid dosage forms, and complex genericsExcellent written and verbal communication skillsDemonstrated leadership and team management capabilities

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