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, Portfolio and Launch Partnership

- Serve as a key strategic partner to Product Management and jointly shape portfolio roadmaps, product strategies and global product launch strategies.
- Provide documented integrated regulatory and clinical assessments for designated portfolio, investment, development and launch decisions.
- Advise on target-market feasibility, classification, claims, evidence requirements, submission pathways, approval timelines, launch sequence and post-market obligations.
- Ensure that regulatory approval status and clinical or scientific evidence availability are included in launch-readiness and commercial-release decisions.

Global Regulatory Affairs

- Provide strategic and technical direction for registrations, submissions,



significant product changes, line extensions, renewals and lifecycle activities.
- Oversee high-quality regulatory documentation, submissions and responses to competent authorities and notified bodies.
- Ensure timely approvals and registrations and fulfillment of authority commitments.
- Maintain complete, accurate and inspection-ready registrations, certificates, commitments and authority correspondence.

Global Clinical Affairs and Evidence

- Develop and govern the global Clinical Affairs and evidence strategy throughout the product lifecycle.
- Oversee clinical evaluations, clinical investigations, post-market clinical follow-up and other proportionate evidence-generation activities.
- Ensure evidence supports intended purpose, target populations, product claims, benefit-risk evaluation, regulatory submissions and lifecycle decisions.
- Identify material evidence gaps and ensure documented mitigation plans, owners, timelines and escalation.
- Provide governance for clinical service providers, investigators and external research partners.

Regulatory and Clinical Integration into Business

- Define mandatory Regulatory Affairs and Clinical Affairs decision points, deliverables and approval criteria in portfolio, development, change, launch and commercialization processes.
- Translate regulatory and clinical requirements into actionable business requirements, responsibilities and implementation plans.
- Ensure Operations and Supply Chain incorporate applicable requirements into manufacturing, sourcing, supplier management, distribution, product changes and market-supply decisions.
- Ensure Marketing, Sales and Commercial functions operate within the approved product status and available evidence, including compliant claims, labeling, promotion and customer communication.
- Assign owners and due dates, monitor implementation, verify effectiveness and escalate overdue or ineffective actions.

Regulatory and Clinical Intelligence

- Establish and govern integrated global regulatory and clinical intelligence across regional and local organizational units.
- Translate emerging requirements, authority expectations, standards and scientific developments into portfolio impacts, evidence plans and implementation actions.
- Report material changes, risks and required management decisions transparently.

RIM System Ownership and Data Governance





- Act as Business System Owner for a Rim system or an equivalent global Regulatory Information Management platform.
- Define intended use, governance, roles, access, data ownership, data standards, process integration and reporting requirements.
- Ensure the RIM system is the authoritative source for designated regulatory data and market-status information.
- Oversee data integrity, validation, access governance, system changes, lifecycle management and continuous improvement.

Global Functional Leadership

- Build, lead and develop an integrated global Regulatory Affairs and Clinical Affairs organization, including regional and local organizational units.
- Define organization, accountabilities, decision rights and escalation pathways and ensure adequate capability, capacity and succession planning.
- Manage the combined budget and external resources and promote a culture of shared regulatory and clinical responsibility.

Education / Professional Certification

- University degree in life sciences, medicine, pharmacy, engineering, regulatory affairs or a related discipline; an advanced degree is preferred.
- At least 10 years of progressive Regulatory Affairs and/or Clinical Affairs experience in regulated healthcare or consumer-health products, with significant global leadership responsibility.

Experience

- Demonstrated experience developing integrated regulatory and clinical evidence strategies across medical devices and other regulated product categories.
- Experience as a strategic partner to Product Management in portfolio planning, market prioritization and global product launch strategies.
- Experience leading interactions with competent authorities and notified bodies and overseeing clinical evaluations, clinical investigations and post-market evidence activities.

Knowledge / Skills / Other characteristics

- Advanced experience as business owner or senior process owner for Rimsys or an equivalent RIM platform, including data governance, validation oversight and lifecycle management.
- Broad knowledge of global regulatory frameworks, ISO 13485, EU MDR, relevant clinical investigation and evidence requirements, and requirements applicable to OTC pharmaceuticals, cosmetics and food products.
- Excellent leadership, governance, stakeholder management, negotiation and communication skills; fluent English.

Working conditions & Other Attributes

- International travel may be required, up to approximately 30% depending on business needs.
- Regular collaboration across different countries, cultures and time zones.

The incumbent performs all activities in accordance with applicable laws, company policies, delegated authorities and the Quality Management System

📌 Head of Global Regulatory Affairs & Clinical Affairs (Bengaluru)
🏢 Zeiss India
📍 Bengaluru