Santosh Kumar Setty

About Santosh Kumar Setty

As an Associate Manager at Novartis, I have over 10 years of experience in clinical operations, pharmaceutical research and development, and clinical supply management. I am passionate about delivering operational excellence and ensuring patient safety by supplying medications on time.I have end-to-end responsibility for assigned projects and portfolios, proactively negotiating and communicating clinical supply plans and timelines to internal and external customers and partners at the global level. I also have expertise in label artwork design, review, and approval, as well as packaging and distribution management. I work in collaboration with cross-functional teams, vendors, and regulatory personnel to ensure compliance and quality standards. I have contributed to multiple successful clinical trials and product launches by providing innovative and effective solutions.

Experience

1. Associate Manager-global Clinical Supply

   Novartis

   Jun 2016 — Present · Hyderabad, IN

   Has operational end-to-end responsibility for assigned Projects and Portfolios. • Proactively negotiating and communicating clinical supply plan/timelines to and liaising with internal and external customers and partners at global level such as Global trial program head, Clinical trial operations team, Labeling and Packaging operations, Formulation and Analytical team, Logistics and Distribution Management team, IRT vendors, QC and QA team. • Phrase Library Management such as discussions with the country responsible Regulatory personnel for the phrase translations, according to their local language and regulatory requirements and performing validation annually. • Support over the Dossier Submission and compiling with DRA\'s and TMF related assistance if any, via subway and irelease, in comply with US, JPN and EMEA- ICH guidelines accordingly. • Handling the Change Control management such as CCP, AQWA, CAPA, TQW investigation over the trial related activities. Document archival in the GxP Environment. • Core label Design/Artwork of the labels in Clinicopia system and trial activities with SAP and IRT involved. • Developing packaging design matching the study design, ensuring optimized supply plan in terms of cost, feasibility and overage at study as well as project level for all IVRS and non-IVRS studies considering country specific regulatory requirements. • Develops, maintains and executes an optimal resupply strategy with proactive planning, appropriate Lead-time and replenishment quantities to ensure compliance and continuity of clinical Supplies, including proactive expiry management of clinical supplies in the IRT system. • Identifying, assessing and proactively communicating supply risks to all relevant stakeholders.

Education

• Vels University

  Masters in Pharmacy

  2009 — 2011

• Trinity college of pharmaceutical sciences

  B

• Krishnaveni Junior College kothagudem,Khammam DT Board of intermediate

  S.S.C

• Vels University

  M