Regulatory Affairs Manager – Taiwan, Hong Kong & Macau (Fixed‑Term)

About the role

As a Regulatory Affairs Manager you will lead registration projects and regulatory activities across Taiwan, Hong Kong and Macau. This one‑year fixed‑term position focuses on new product licensing, manufacturing site changes and maintaining existing licences to ensure business continuity and compliance with local laws and Elanco policies.

Key responsibilities

• Compile registration dossiers and prepare local regulatory documents (package inserts, packaging components) for new listings, renewals and variations.
• Liaise with Quality Assurance, Supply Chain and CMC teams to meet regulatory requirements and ensure seamless product supply.
• Build and maintain relationships with the Taiwan regulatory agency (APHIA) and work with Hong Kong/Macau distributors to facilitate registrations.
• Manage regulatory documentation in systems such as Veeva, ensuring data accuracy and adherence to submission timelines.
• Act as Deputy Local Pharmacovigilance Manager, reporting adverse events and product complaints per internal procedures.

Required profile

• Bachelor’s degree in Veterinary Medicine, Animal Science, Pharmacy, Chemical or Medical Sciences.
• Minimum 2 years experience in veterinary or pharmaceutical regulatory affairs (5+ years preferred for manager level).
• Excellent bilingual communication skills in English and Chinese and proficiency with the MS Office suite.

Required skills

• Experience with Veeva or similar regulatory documentation systems.
• Proficiency in MS Office Suite.
• Familiarity with AI tools to improve work efficiency or data management.
• Knowledge of Taiwan veterinary drug and animal feed regulations.
• Strong attention to detail and data quality.