Sandesh V. Shetty

About Sandesh V. Shetty

Highly skilled, result-oriented Senior Regulatory Affairs Professional with over 13 years…

Experience

1. Senior Manager Regulatory Affairs

   Micro Labs Limited

   Apr 2016 — Present · Bengaluru, IN

   Spearheading entire team to manage the Regulatory Deliverables by timely submission to various Regulatory Authorities across the USA, Canada and Europe.• Scrutinizing CMC documents for submission of initial product registration applications of solid oral dosage form, injectable and ophthalmics to USFDA (ANDA), Europe (MAA) and Canada (ANDS).• Develop high-quality and globally aligned regulatory strategies for post-approval submissions to USFDA (viz. CBE-30 PAS and Annual Reports).• Conducting regular meetings and reviews with internal team members like project managers, formulation and analytical teams, etc, regarding new and site transfer product development.• Coordinating with every department for Dossier filing, covering all eCTD/CTD and country-specific checklists to comply with the respective regulatory bodies.• Engage in communication with regulatory authorities and authoring Module 1 for regulatory submissions.• Report and review discrepancies, deviations, and deficiencies, if any, coordinate with the manufacturing department and make necessary corrections to bridge the gaps systematically, involving regulatory guidance and internal checklists.• Evaluating and sharing the RA requirements with the product development team during the development stage and reviewing critical documents like specifications, stability protocols, stability data and justification reports.• Identifying all open issues and anticipated questions on regulatory submission at the respective stage of product development, dossier filing and deficiency responses.• Ensuring all critical points have been cleared in consultation with cross-functional teams in USA, Europe and Canada.• Generating Regulatory Gap Assessment Report whilst extending dossiers from vivid regions to Canada & USA.• Managing the payment of all the USFDA-GDUFA user fees as per the corresponding FY rates, including ANDA program fees, Facility fees and ANDA fees.

Skills

• Ectd
• Regulatory Submissions
• Generic Programming
• Regulatory Affairs
• Validation
• Formulation
• Pharmaceutics
• Anda
• Gmp
• Glp
• Pharmaceutical Industry
• Sop
• Fda