Umachandar Lagisetty

About Umachandar Lagisetty

Design global CMC regulatory strategies for development projects with creativity and innovation by maintaining regulatory compliance for maximum business benefit.•Sound Technical knowledge in various complex generics, including solid orals, osmotic pumps, semisolid, transdermal patches, subligual films, topical foams, sprays, drug devices.•Exposure to US-FDA, Health Canada, MHRA and ROW markets. •Involving in FDA meetings by preparing development packages and dossier meeting packages for complex products including device combination products.•Liaison with CFT’s to get effective and timely submissions of ANDA’s, deficiency responses and supplemental filings.•QbD designing to maintain quality of product with technical evaluation of products to get approvals within GDUFA goal dates.•Pre facility correspondences, controlled correspondence, complex generic meetings and pre ANDA meeting with FDA. •Planning, authoring, reviewing, coordinating, submission of assigned projects, while applying the global strategy into submissions. Make quality regulatory decisions, balancing risks and benefits.•To support eCTD and lableinig teams. •Establish and maintain sound working relationships with partners and customers. •Preparing pre-ANDA/briefing packages to initiate and lead FDA interactions and negotiations as appropriate.•Technical presentations with higher management on risk evaluation points with proper contingency plans to smooth flow of submissions as per business requirements.

Experience

1. Manager Global Regulatory Affairs

   Abbott

   Feb 2020 — Present · Mumbai, IN

Education

• Jawaharlal Nehru Technological University

  Doctor of Philosophy - PhD, Pharmacology

• Kakatiya University (University College of Pharmaceutical Sciences)

  M.Pharmacy, Pharmacology

  2007 — 2009