Naveen Kumar Nagaraja

About Naveen Kumar Nagaraja

Regulatory Affairs Leader | 22 Years | Pharmaceutical MNCs | India RegionExperienced Regulatory Affairs professional with over two decades of leadership across top pharmaceutical multinationals. I specialize in regulatory strategy, clinical trial approvals, product lifecycle management, and regulatory operations setup — supporting innovative therapies including first-ever gene therapies in India.Throughout my career at companies like Miltenyi Biotec, Abbott, Novartis, and Takeda, I’ve built high-performing regulatory teams, secured critical product approvals, led complex HA negotiations, and contributed to shaping regulatory policy through industry associations (e.g, OPPI, ISCR).Passionate about driving regulatory excellence, accelerating market access for innovative therapies, and mentoring the next generation of regulatory professionals.Key Areas of Expertise: • Regulatory Strategy & Health Authority Engagement • Clinical Trials & Innovative Therapy Approvals (Cell and Gene Therapy) • Business Development Regulatory Support • Risk Management | Crisis Resolution | Regulatory Compliance • Cross-Functional Leadership | Talent Development • QMS & Pharmacovigilance Systems

Experience

1. Regulatory Affairs Director

   Miltenyi Biotec

   Feb 2024 — Present · Mumbai, IN

Education

• Bangalore University

  Bachelor of Pharmacy - BPharm, Pharmacy

  1995 — 1999

• Bangalore University

  MBA, Marketing

  2000 — 2002

Skills

• Quality Assurance
• Biotechnology
• Strategy
• Diabetes
• Regulatory Affairs
• Life Sciences
• Cardiology
• Market Access
• CRO
• Clinical Trials
• Validation
• Pharmaceutics
• Standard Operating Procedure (Sop)
• Clinical Research
• Regulatory Requirements
• Oncology
• Pharmaceutical Sales
• CRO Management
• Management
• Drug Development
• Gcp
• Regulatory Submissions
• Pharmaceutical Industry
• Sop
• Fda
• Drug Safety
• Quality System
• Pharmacovigilance
• Gmp
• Clinical Development
• Product Launch