Regulatory Execution Hub Team Lead

Location: Seoul, Republic of Korea; hybrid work arrangement

Company

hirify.global is a biopharmaceutical company operating across global regulatory and product portfolios.

What you will do

• Lead Regulatory Operations Hub Coordinators and Managers delivering local M1 dossier components and regulatory support across assigned countries and clusters.
• Manage regulatory activities across the product lifecycle, from initial applications and commercial launch through product withdrawal.
• Oversee authoring, review, translation, and submission preparation for local documents, including cover letters, variations, marketing authorization applications, labels, and artwork.
• Act as the initial escalation point for regulatory issues, performance monitoring, audit readiness, and compliance activities.
• Partner with Submission Hubs, Regional Hubs, Growth Submission Managers, local affiliates, and cross-functional stakeholders to coordinate priorities and deliver submissions.
• Build a high-performing team through goal setting, talent development, succession planning, KPI management, and continuous improvement.

Requirements

• Master’s-level education such as an MS or MBA in a scientific, technical, or information management discipline, or equivalent professional experience.
• Understanding of global, regional, and cluster regulatory requirements, trends, biopharmaceutical industry processes, and regulatory safety practices.
• Proven leadership experience in regulatory strategy and/or regulatory operations, including delivery of complex portfolios across multiple markets.
• Experience with strategic business planning, operations, submission and portfolio management, and large cross-site change programs.
• Strong communication, relationship-building, business judgment, organizational management, decision-making, and conflict-management skills.
• Ability to manage high work volumes, multiple demands, tight timelines, ambiguity, and collaboration across multiple countries and cultures.

Culture & Benefits

• Hybrid work arrangement in Seoul, Republic of Korea.
• Focus on inclusion, diversity, leadership development, and communities of practice.
• Emphasis on continuous improvement, innovation, ownership, agility, and operational excellence.
• Equal opportunity employment in accordance with applicable legislation.