Purpose of this position / Position summary
The Global Head of Regulatory Affairs & Clinical Affairs provides strategic and functional leadership for Regulatory Affairs and Clinical Affairs worldwide. The role covers medical devices, over-the-counter pharmaceuticals, cosmetics and food products, including products at the interface of these regulatory categories.
The position develops and governs integrated global regulatory and clinical evidence strategies to support portfolio decisions, product development, market access, global product launches and lifecycle compliance. As a key strategic partner to Product Management, the role advises on regulatory pathways, product classification, clinical and scientific evidence, claims, market prioritization, launch sequencing, approval timelines and post-market obligations.
The role leads the global Regulatory Affairs and Clinical Affairs organization, including its regional and local organizational units.



It ensures that regulatory and clinical requirements are translated into explicit business requirements and embedded in the processes and decisions of Product Management, R&D;, Medical and Scientific Affairs, Quality, Operations, Supply Chain, Marketing, Sales and other relevant functions.

Primary duties and responsibilities
Global Regulatory and Clinical Strategy
• Develop, align and own integrated global Regulatory Affairs and Clinical Affairs strategies in accordance with business objectives, portfolio priorities and global market-access plans.
• Define product-category-specific regulatory pathways and proportionate clinical or scientific evidence strategies for medical devices, OTC pharmaceuticals, cosmetics and food products.
• Ensure coherent strategy and execution across regional and local organizational units while addressing justified market-specific requirements.
• Identify and govern product-classification, borderline-product, claims-substantiation and evidence risks at an early stage.

Strategic Product Management,

📌 Head Of Global Regulatory Affairs Bengaluru
🏢 Zeiss India
📍 Bengaluru