Regulatory Affairs Manager

At Elanco (NYSE: ELAN) – it all starts with animals!

As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets.

At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose – all to Go Beyond for Animals, Customers, Society and Our People.

At Elanco, we pride ourselves on fostering a diverse and inclusive work environment.

We believe that diversity is the driving force behind innovation, creativity, and overall business success.

Here, you’ll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.

Making animals’ lives better makes life better – join our team today!

Your Role: Regulatory Affairs Manager (Fixed Duration Employee)

As a Regulatory Affairs Manager, you will be responsible for registration projects and regulatory activities in Taiwan, Hong Kong, and Macau.

In this one-year fixed-term role, you will focus on new product licensing, manufacturing site changes, and maintaining existing licenses to ensure business continuity and compliance with local laws and Elanco policies.

Your Responsibilities:


* Independently compile registration dossiers and prepare local regulatory documents such as package inserts and packaging components for new listings, renewals, and variations.


* Liaise with cross-functional teams including Quality Assurance, Supply Chain, and CMC to fulfill regulatory requirements and ensure seamless product supply.


* Build and maintain professional relationships with the Taiwan regulatory agency (APHIA) and collaborate with Hong Kong/Macau distributors to facilitate registration processes.


* Manage local regulatory documentation within systems like Veeva, ensuring high data accuracy and strict adherence to submission timelines.


* Act as the Deputy Local Pharmacovigilance Manager, reporting Adverse Events and Product Complaints in compliance with internal procedures.

What You Need to Succeed (minimum qualifications):


* Education: Bachelor’s degree in Veterinary Medicine, Animal Science, Pharmacy, Chemical, or Medical Sciences.


* Experience: A minimum of 2 years of experience in Veterinary or Pharmaceutical regulatory affairs (5+ years required for Manager level).


* Excellent bilingual communication skills (English and Chinese) and proficiency in MS Office Suite.

What will give you a competitive edge (preferred qualifications):


* Familiarity with Taiwan veterinary drug and animal feed regulations.


* Experience utilizing AI tools to improve work efficiency or data management.


* Highly detail-oriented with a strong focus on data quality and precision.


* Proven ability to work under pressure and comply with strict deadlines.


* Proactive mindset with strong learning agility and results o...