Hidaytulla aga

Skills

✅ CORE EXPERTISE:

Global R&D Strategy | Facility Engineering & Commissioning (C2C) | Complex Generics | AI-First R&D Ecosystems | P&L Management | CMC & Regulatory Affairs | Strategic Alliances | M&A Due Diligence | Organizational Transformation | MS&T Governance

About

Enterprise R&D Leader | Digital & Infrastructure Strategist

I view R&D not as a cost center, but as a primary engine for enterprise value. With over 27 years of evolution from bench scientist to Vice President & Head of R&D, I specialize in building "Business-First" engines that bridge the gap between complex science and commercial success.

I bring 14+ years of senior leadership experience in technical due diligence, CDMO/CRO oversight, regulatory defense, and enterprise-level decision-making.

My leadership is defined by a P&L mindset—transforming R&D into a driver of market exclusivity. By merging technical mastery with strategic portfolio stewardship and comprehensive facility engineering, I turn scientific breakthroughs into high-growth, regulatory-compliant assets.

🚀 STRATEGIC IMPACT HIGHLIGHTS:
Infrastructure & Facility Engineering (C2C): Directed the end-to-end engineering and commissioning of state-of-the-art R&D facilities (OSD, Oral Liquids, and Injectables) from initial concept and URS to global regulatory readiness at Cipla, Glenmark, and Umedica. Portfolio Stewardship: Managed global portfolios of 500+ products, generating $150M+ in incremental revenue via Para IV programs and lifecycle management. Digital Innovation: Early adopter of AI-driven formulation modeling and In Silico analytics, reducing development cycle times by 20–35%.
Regulatory & CMC Excellence: Navigated USFDA, EMA, GCC, and APAC landscapes to steer 300+ filings with a ~95% first-cycle approval rate. Operational Scale: Directed annual budgets of ₹55–65 Crores, optimizing vendor strategies to improve cost competitiveness by up to 18%.
Technical Mastery: Led 300+ technology transfers with a 98% success rate, reducing COGS by ~30% through process optimization.

💡 THE "FUTURE-READY" PHILOSOPHY: As an Executive MBA holder and Global CXO community member, I am committed to the organizational evolution of Pharma. I focus on building high-performance cultures where technical experts transition into strategic enterprise leaders. I am passionate about mentoring the next generation of scientists and collaborating with global partners to bring life-changing medications to market faster.