Hiren D. Bhagat

• Almost 18 years of exclusive experience in pharmaceutical regulatory affairs, formulation development, technology transfer, and project management for solid oral, injectable, liquid, and respiratory dosage forms for international markets.
• Primarily accountable for New Drug Product Dossier submission, approval, commercialization, and life cycle management for NMPA (China), TGA (Australia), MEDSAFE (New Zealand), ANVISA (Brazil), SFDA (Saudi Arabia), JFDA (Jordan), EDE (UAE), WHO-PQ (Geneva), Morocco, Turkey and other Latin American countries (Chile, Panama, Colombia, Honduras, Ecuador, Bolivia, etc.).
• A comprehensive understanding of the regulatory processes for SAHPRA (South Africa), Thai FDA (Thailand), TFDA (Taiwan), NMRA (Sri Lanka), and various other countries in the Asia-Pacific region.
• Responsible for the technical review of initial dossiers, deficiency responses, post-approval variation packages, post-approval surveillance reports, product labeling, and other promotional materials.
• Maintain a thorough understanding of regulatory dynamics, and further support the business team for strategic alliances or expansion.
• Develop and execute regulatory strategies and plans to ensure compliance with applicable regulations and standards.
• Collaboration with cross-functional teams, including Business Development, R&D, Manufacturing, QA, and Legal, to ensure that all regulatory requirements are met throughout the product lifecycle.
• Liaise with regulatory authorities, and act as the primary point of contact during GMP inspections and other control correspondence.
• Monitor and track regulatory compliance metrics, and translate them into actionable items for further discussion with senior management.
• Present designation: Deputy General Manager (team size: 16).

Formulation Development & Technology Transfer

Formulation Development & Project Management