Regulatory Sciences Manager

Location: Hybrid, Makati City, Philippines

Company

hirify.global is a pharmaceutical company developing and commercializing medicines and managing regulatory activities across global markets.

What you will do

• Develop local regulatory strategies for licensed and development products and provide regulatory input to cross-functional commercial and R&D teams.
• Manage national marketing authorization applications, pre-submission meetings, regulatory authority engagements, and negotiations.
• Coordinate variation, renewal, cancellation, discontinuation, divestment, and supply interruption activities.
• Respond to regulatory authority queries and communicate submission progress, decisions, risks, and delays to stakeholders.
• Support packaging and prescribing information updates, unlicensed medicine approvals, third-party licences, and medical device activities.
• Maintain regulatory databases and contribute to Good Regulatory Practice, inspection readiness, process improvements, and regulatory team development.

Requirements

• Bachelor of Science in Pharmacy or an equivalent degree; an MBA or MS may be advantageous.
• Registered Pharmacist in the Philippines.
• At least 6 years of professional experience in regulatory sciences.
• Fluent English with strong written and spoken communication skills.
• Experience across the drug discovery, development, commercialization, and product lifecycle stages, including CTA and NDA submission processes.
• Experience managing strategic regulatory activities, regulatory issues, and delivery in a complex matrix environment.

Nice to have

• Higher degree such as an MBA or MS.
• General management, line management, or leadership experience.
• Regional regulatory experience.

Culture & Benefits

• Hybrid work arrangement.
• Equal opportunity employment environment.
• Opportunities to contribute to regulatory team development and special projects.
• Support for professional training, development, and career growth.