Senior Associate, ESOQ Regulatory Operations (Pharmaceuticals)

Location: Makati City, Philippines; hybrid work arrangement

Company

hirify.global develops and maintains products designed to meet high standards of quality and safety for patients worldwide.

What you will do

• Support post-approval changes, initial registrations, renewals, regulatory commitments, and Board of Health queries.
• Perform preliminary regulatory impact assessments and raise change management records in relevant GMP systems.
• Coordinate supporting documentation and act as a liaison between CMOs and internal hirify.global functions.
• Provide regulatory expertise to the Virtual Site Operating Team, including advice on regulatory strategy and potential supply constraints.
• Support dossier compliance assessments, implementation of new regulations and compendia requirements, and investigations into regulatory discrepancies.
• Manage commercial drug product, medical device, and combination product complaints and review SAP material master workflow tasks.

Requirements

• At least 5 years of experience in a GxP setting and/or Regulatory Affairs, or 3 years with a master’s degree.
• Expertise in change management and/or regulatory affairs, with experience using relevant QTS and eQMS modules.
• Knowledge of US, European, and global cGMPs, compliance issues, inspectional trends, quality assurance practices, and regulatory guidelines.
• Experience in pharmaceutical quality assurance or quality control, with a fundamental understanding of QA and GMP principles.
• Proficient English and technical writing skills are required.
• Strong communication, presentation, interpersonal, project leadership, decision-making, and independent working skills.

Nice to have

• Experience working in a matrix environment and with supplier quality management.
• Experience collaborating with cross-functional teams and adapting to changing priorities.
• Experience using generative AI tools such as ChatGPT or Microsoft Copilot, including responsible AI and risk management practices.

Culture & Benefits

• Hybrid work arrangement in Makati City, Philippines.
• Global collaboration across internal functions, CMOs, and virtual site operating teams.
• Quality culture based on science, risk-based compliance, innovation, and customer focus.
• Work environment aligned with courage, equity, excellence, and joy.