Execution Hub Sr. Associate (Regulatory Affairs)

Location: Hybrid in Makati City, Philippines

Company

hirify.global is a global pharmaceutical company developing and delivering medicines and vaccines.

What you will do

• Manage regulatory dossiers and submission activities across assigned countries, clusters, therapeutic areas, and products.
• Author, review, and coordinate local M1 dossier components, including cover letters, variations, marketing authorization applications, and translations.
• Review and approve dossier tables of contents and submission-ready documents provided by Hub Submission and Dossier Managers.
• Prepare simple health authority query responses and coordinate complex responses with relevant subject matter experts.
• Support tenders, out-of-stock reporting, annual product quality reviews, risk minimization plans, launch planning, audit readiness, and healthcare professional communications.
• Partner with Country Regulatory Strategists, Submission Hubs, Labeling Hubs, and cross-functional teams to ensure timely, compliant delivery.

Requirements

• B.S. in Pharmacy or equivalent relevant professional experience.
• Advanced to fluent English; multilingual skills are desirable.
• Experience in pharmaceutical regulatory affairs, quality, or compliance is preferred.
• Understanding of country or cluster regulatory requirements and trends is preferred.
• Advanced Microsoft Office Suite skills and the ability to quickly learn new software, regulations, and quality standards.
• Senior-level performance requires independent problem solving, handling ambiguity, recognizing escalation needs, and demonstrating technical expertise in submission execution.

Culture & Benefits

• Hybrid work arrangement based in Makati City.
• Collaboration with international country, cluster, regional, and submission teams.
• Work focused on timely delivery, quality, regulatory compliance, and process efficiency.
• Equal employment opportunity practices apply in accordance with local legislation.