Regulatory Execution Hub Sr. Associate (Pharma)

Location: Seoul, South Korea; hybrid work arrangement

Company

hirify.global is a pharmaceutical company developing and delivering medicines across global markets.

What you will do

• Manage regulatory dossiers for assigned countries, clusters, therapeutic areas, and products from initial registration through lifecycle management and product withdrawal.
• Author, review, coordinate, and deliver local M1 dossier components, including cover letters, variations, marketing authorization applications, and translations.
• Prepare simple health authority query responses and coordinate complex responses with relevant subject matter experts and functions.
• Review and approve dossier build tables of contents and support timely, high-quality submission delivery.
• Support tenders, out-of-stock reporting, Annual Product Quality Reviews, risk minimization plans, launch planning, audit readiness, and healthcare professional communications.
• Identify and escalate quality, compliance, and emerging risks while implementing portfolio execution efficiencies.

Requirements

• Bachelor’s degree in Pharmacy, Life Sciences, Business, Information Technology, or equivalent relevant professional experience.
• Advanced to fluent Korean and English required.
• Technical aptitude and ability to quickly learn new software, regulations, and quality standards.
• Advanced Microsoft Office Suite skills.
• Understanding of country or cluster regulatory requirements and trends.
• Relevant pharmaceutical, regulatory, quality, or compliance experience.

Culture & Benefits

• Hybrid work arrangement in Seoul.
• Collaboration with Country Regulatory Strategists, Hub Submission Managers, Regional Submission Hubs, and cross-functional experts.
• Equal employment opportunity workplace complying with applicable legislation.