Ramesh Dandu

About Ramesh Dandu

I am passionate about applying my R&D development expertise (from the US generic industry) and the regulatory perspective honed during my stint at the US FDA, to drive regulatory strategy and life cycle management for generics. Working with three of the top 5 generics in the US in the last decade (Actavis, Sandoz and Par Pharmaceuticals) has helped me deepen my understanding of the operational challenges in the hyper competitive US generics market place. Working in India, after more than two decades of study/work in the US, has opened up new exciting learning opportunities and a new perspective on global product development happening in India. I am excited to take these learnings and provide strategic solutions for complex regulatory and compliance issues for the global markets by building a motivated team at MSN.Facility review work at the US FDA related to pre-approval inspection (PAI) program for NDAs/ANDAs and the compliance consulting stint at Parexel has provided me audit exposure at biologics, parenteral, solid oral and API facilities in multiple countries (eg: India, Europe, S Korea, and Japan). I plan to use the different optics and thoughts I have on compliance strategy for optimal utilization of facilities for global markets.

Experience

1. Sr General Manager Regulatory Affairs and Compliance

   MSN Laboratories

   Oct 2023 — Present · Hyderabad, IN

   Providing strategic guidance and solutions for complex regulatory and compliance issues, supporting GXP audits and assessments, designing and developing quality systems, and supporting regulatory interactions by building a motivated team at MSN.My mission is to develop regulatory and quality systems that facilitate timely approval, launch and manufacture of safe, efficacious, and quality pharmaceutical products for patients.

Education

• University of Mysore

  BS, Pharmacy at JSS College of Pharmacy

  1994 — 1998

• University of Maryland School of Pharmacy

  PhD, Pharmaceutical Sciences

  2002 — 2008

Skills

• Gmp
• Protein Chemistry
• Formulation Development
• Formulation
• Drug Delivery
• Regulatory Affairs
• Glp
• Life Sciences
• Standard Operating Procedure (Sop)
• Laboratory
• Quality by Design
• Pharmaceutical Industry
• Sop
• Fda
• Polymers
• Regulatory Requirements
• Biotechnology
• Design of Experiments
• Pharmaceutics
• Good Laboratory Practice (Glp)
• Pharmaceutical Research
• U.s. Food and Drug Administration (Fda)