Description
Lead the global regulatory affairs function to secure product approvals, ensure ongoing compliance with regulations and SOPs, and align regulatory strategy with business objectives across the product lifecycle.
- • Set the global regulatory vision, strategy, and governance aligned to corporate goals.
- • Oversee the preparation and timely submission of global regulatory applications, reports, and correspondence.
- • Approve regulatory strategies for new products, indications, and lifecycle changes.
- • Establish and enforce regulatory affairs policies, SOPs, and quality standards.
- • Allocate budgets, headcount, and priorities across the regulatory portfolio.
- • Provide executive regulatory guidance to R&D, clinical, quality, manufacturing, and commercial teams.
- • Ensure accuracy, completeness, and compliance of all submissions and agency interactions.
- • Represent the company before FDA, EMA, and other authorities; negotiate complex issues and commitments.
- • Direct inspection readiness and lead responses to audits, inspections, and enforcement actions.
- • Oversee complaint handling systems, investigations, and required agency notifications.
- • Review and approve promotional, labeling, and user documentation for regulatory compliance.
- • Lead development and approval of clinical trial regulatory strategies and protocols.
- • Provide strategic responses to agency questions, deficiency letters, and advisory committee matters.
- • Monitor and communicate emerging regulations and policy trends; assess business impact.
- • Drive organizational readiness and change management for new or revised regulations.
- • Establish enterprise procedures and systems for electronic publishing and document control.
- • Evaluate and select regulatory information management and publishing technologies.
- • Build, mentor, and develop a high-performing global regulatory team; oversee training.
- • Coordinate major matters with Legal, including internal investigations, discovery, and product liability.
- • Lead regulatory aspects of product recalls, field actions, and crisis management.
- • Engage industry groups and policymakers to shape regulatory policy relevant to the business.
- • Oversee environmental and sustainability-related regulatory matters, where applicable, ensuring alignment with corporate initiatives.
- • Contribute regulatory input to corporate strategic planning, portfolio decisions, and business development.
- • Track KPIs and drive continuous improvement across regulatory processes and outcomes.
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O*NET occupational data (work activities, skills, knowledge).
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Last reviewed: Jan 2026
