RIO Execution Hub Sr. Associate (Regulatory Affairs)

Location: Makati City, Philippines; hybrid

Company

hirify.global is a pharmaceutical company operating across international regulatory markets.

What you will do

• Manage multi-regional, regional, and national regulatory dossiers across initial registrations, lifecycle management, and product withdrawal.
• Author, review, and coordinate local M1 dossier components, cover letters, variations, marketing authorization applications, and relevant translations.
• Prepare simple health authority query responses and coordinate complex responses with subject matter experts and cross-functional teams.
• Review and approve dossier build tables of contents and support timely, submission-ready dossier 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, or Information Technology, or equivalent relevant professional experience.
• Advanced to fluent English is required.
• Relevant experience in pharmaceutical regulatory affairs, quality, or compliance is preferred.
• Understanding of country or cluster regulatory requirements and trends is preferred.
• Strong technical aptitude, ability to learn new software and regulations quickly, and advanced Microsoft Office skills.
• Ability to self-initiate problem solving, navigate ambiguity, and recognize when escalation is required.

Nice to have

• Multilingual skills.
• Familiarity with pharmaceutical organizational structures, systems, and culture.
• Subject matter expertise supporting projects involving people, technology, or processes.

Culture & Benefits

• Hybrid work arrangement.
• Cross-functional collaboration with country and cluster regulatory teams, submission hubs, GI&PE, GRS, and local affiliate functions.
• Equal opportunity employment in accordance with applicable local legislation.