Description
Lead the regulatory affairs function, setting global strategy and overseeing submissions, compliance systems, and authority interactions across the product lifecycle to secure approvals and sustain market access.
- • Direct the preparation and global submission of regulatory applications, reports, and correspondence.
- • Set regulatory strategy and governance policies to ensure sustained compliance and market access.
- • Provide senior regulatory guidance to R&D, clinical, quality, and commercial teams on design, development, labeling, and marketing.
- • Communicate regulatory requirements and decisions across functions and ensure consistent interpretation.
- • Develop and approve regulatory strategies and timelines for new product approvals and indications.
- • Establish regulatory priorities, budgets, and resource plans; deploy and balance workloads.
- • Oversee complaint handling, vigilance/MDR reporting, and post-market surveillance processes.
- • Oversee investigations of product complaints and ensure timely documentation and agency submissions.
- • Maintain and disseminate current knowledge of global regulations and guidances; assess business impact.
- • Lead readiness for and responses to audits, regulatory inspections, and enforcement actions.
- • Monitor emerging regulatory trends and policy changes to inform portfolio and process adjustments.
- • Provide regulatory leadership in clinical development plans, protocols, and study conduct.
- • Approve and oversee responses to health authority questions and information requests.
- • Represent the company before domestic and international regulatory agencies and industry bodies.
- • Review and sign off on submission packages to ensure accuracy, completeness, and compliance.
- • Oversee review of labeling, advertising, and promotional materials for regulatory compliance.
- • Build, mentor, and train regulatory staff; develop competencies and succession plans.
- • Align regulatory objectives with corporate and business unit strategic and operating plans.
- • Partner with Legal on regulatory inquiries, investigations, and litigation support.
- • Establish, maintain, and improve SOPs, work instructions, and regulatory quality systems.
- • Oversee electronic publishing and submission systems and ensure compliant document control.
- • Evaluate and implement new regulatory technologies and standards for electronic submissions.
- • Build and maintain constructive relationships with health authorities and key external stakeholders.
- • Lead lifecycle management, including variations, supplements, labeling changes, and renewals.
- • Drive cross-functional change control and risk management for regulated products and processes.
- • Direct documentation and records management to meet domestic and international standards.
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Management & Entrepreneurship
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O*NET occupational data (work activities, skills, knowledge).
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Last reviewed: Jan 2026
