Arun Mendiratta

About Arun Mendiratta

Delivered 30 years of executive leadership in pharmaceutical analytical development, enabling successful development and approval of complex injectable drug products including peptides, oligonucleotides, liposomes, nanoparticles, microspheres, and iron colloids.• Defined and executed global analytical and regulatory strategies, establishing QbD-based control frameworks that consistently supported first-cycle and timely global regulatory approvals.• Enabled successful regulatory approvals for multiple complex injectable products, including Iron Sucrose, Ferric Carboxymaltose, Amphotericin, Octreotide, Paliperidone (1-month and 3-month depot formulations), and Difluprednate.• Designed and implemented sameness and comparability strategies for parenteral products, ensuring robust analytical justification across development phases from early formulation through commercial launch.• Built and governed QbD-driven analytical frameworks, aligning control strategies with CTD, ICH, and global regulatory requirements to support high-quality submissions and inspections.• Led direct scientific and development engagements with the US FDA, including face-to-face meetings, shaping development programs aligned with evolving regulatory expectations and de-risking approval pathways.• Directed critical regulatory responses (CRLs) for complex injectables, integrating updated FDA scientific thinking and insights gained through collaboration with CRCG and academic research partners.• Spearheaded end-to-end leadership of Analytical Research, Corporate Quality Control, Quality Excellence, Innovation, and Quality Management, delivering sustained compliance and performance across Generics API, OSD formulations, and NCE portfolios.

Experience

1. Head, Analytical Research-injectables

   Viatris

   Jan 2021 — Present · Bangalore urban, IN

   Leading analytical development and characterization across peptides, oligonucleotides, liposomes, nanoparticles, microspheres, and iron colloids.• Define and execute sameness and comparability strategies, analytical control approaches, and technology transfer to enable parenteral product development from early clinical phases through commercialization.• Drive QbD-based analytical frameworks, ensuring alignment with CTD/ICH regulatory requirements and leveraging advanced analytical platforms to support global submissions and approvals.• Lead regulatory engagements with the US FDA, including face-to-face product development and scientific advice meetings, to align development strategies with regulatory expectations and accelerate approval pathways.• Oversee and lead responses to regulatory queries (CRLs) for complex injectables, integrating evolving FDA scientific perspectives informed by collaborative work with CRCG and academic research institutions.

Education

• Delhi University

  M. Pharm., Pharmaceutics (Gold Medalist)

  1990 — 1996