Hardik Rathod

About Hardik Rathod

At Sandoz our purpose is pioneering access for patients to become the world’s leading and most valued Generics and Biosimilars company. The global leader in affordable medicines.Hardik Rathod is an Associate in Regulatory Generics Lifecycle and International Submission for Sandoz Small Molecules. He brings around 8.5 years of experience in driving business performance through quality Regulatory submissions, maximizing and utilizing current and novel regulatory strategies to ensure “On Time” and “First Time” approval and “On Time” launch for business continuity and pioneering access for the patients. Hardik is avid learner and keeps close eye on current regulatory updates across the globe. Hardik is passionate about providing support beyond his responsibilities and ensure Best Customer Experience (CEx) to both Internal and External customers to achieve department objectives. He likes to do close collaboration with stakeholders globally, in the region including Production site, Portfolio, Supply Chain, BD, Launch, Country RA department to cater business needs.

Experience

1. Senior Regulatory Affairs Specialist

   Sandoz

   Oct 2025 — Present · Mumbai, IN

   Tasks- Operational responsibility for defined projects/activities with oversight- Contribute to project strategy and execution- Independent problem solving of routine issues and new issues and fixing of process gaps to achieve continuous improvement- Contribute to cross-functional strategy workstreamsCapability- Strong subject matter understanding and/or scientific capabilities- Ability to independently identify, prioritize, and deliver necessary operational tasks- Seeks and accepts feedback and acts on it- Quality and Compliance: Able to generate high quality and compliant documents. Able to understand, generate and implement efficient processes and SOPs in accordance with level of experience and expertise. Ensures maintenance of appropriate systems and their correct and compliant use. Able to support external audits and support regulatory relevant aspects of the Quality Management System.Leadership- Competent delivery of project and activity operations – proactively integrates and aligns activities within team / within area of expertise, in accordance with level of experience and seniority- Exhibits strong V & BAgility and communication- Change agility – ability to deliver operational tasks in dynamic environment- Proactively / independently engages and collaborates with internal stakeholders and line functions- Good influencing and negotiation skills- Can clearly communicate complex topics to other experts

Education

• Institute Of Chemical Technology

  B.Tech, Pharmaceutical Sciences and Technology

  2013 — 2017