(Sr) RA Specialist (Regulatory Affairs)

Location: Taipei, Taipei City, Taiwan

Company

hirify.global develops healthcare products and solutions focused on its mission to save and sustain lives.

What you will do

• Coordinate regulatory strategies with Global Regulatory Affairs and business units for product development and commercialization.
• Prepare and submit regulatory documents, including New Drug Applications, Plant Master Files, Drug Master Files, license renewals, variations, and other submissions.
• Maintain regulatory systems, trackers, and databases, and evaluate and communicate new or changing regulations, guidance, and standards.
• Act as a primary contact for regulatory agencies, responding to inquiries and providing requested information.
• Collaborate with R&D, Quality Assurance, Pharmacovigilance, manufacturing, business units, and marketing.
• Assess and approve product labeling, packaging, and advertising materials for regulatory compliance and accurate scientific claims.

Requirements

• Expert knowledge of drug regulations.
• Good communication and problem-solving skills.
• Excellent time management and project management skills.
• Ability to collaborate effectively across functions.
• Pharmacy qualification is preferred.

Culture & Benefits

• Work in a culture built around courage, trust, collaboration, ownership, and accountability.
• Contribute to healthcare delivery and products supporting hirify.global's mission to save and sustain lives.
• Equal employment opportunity is provided regardless of legally protected characteristics.
• Reasonable accommodations are available for candidates with disabilities during the application and interview process.