Regulatory Affairs Manager

Elanco; United States; On-site; USD 38,000 - 56,000; Full time

Job summary

Elanco seeks a Regulatory Affairs Manager (Fixed Duration) to oversee registration projects in Taiwan, Hong Kong, and Macau. This role focuses on new product licensing, site changes, and maintaining licenses to ensure compliance and continuity, reporting to the local regulatory leadership.

The ideal candidate holds a bachelor’s in a relevant field, with 2+ years in regulatory affairs (5+ for manager level) and strong English/Chinese communication, along with MS Office proficiency.

Qualifications

• Bachelor’s degree in Veterinary Medicine, Animal Science, Pharmacy, Chemical, or Medical Sciences.
• Minimum 2 years in veterinary or pharmaceutical regulatory affairs; 5+ years for Manager level.
• Excellent bilingual English and Chinese; proficiency in MS Office.

Responsibilities

• Compile registration dossiers and create local regulatory documents for listings, renewals, and variations.
• Coordinate with QA, Supply Chain, and CMC to meet regulatory requirements.
• Engage with Taiwan APHIA and HK/Macau distributors to facilitate registrations.
• Manage local regulatory documentation in systems like Veeva with high data accuracy.
• Act as Deputy Local Pharmacovigilance Manager for adverse events and product complaints.

Skills

Bilingual English-Chinese

MS Office

Regulatory affairs

Cross-functional collaboration

Education

Bachelor's degree in Veterinary Medicine/Animal Science/Pharmacy/Chemical/Medical Sciences

Tools

Veeva Systems

Job description

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 orientation.

Additional Information:

• Location: Taipei, Taiwan - On-site

Don't meet every single requirement? Studies have shown underrecognized groups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles!

Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status

Elanco may use automated tools, including AI, to support parts of our recruitment process, such as reviewing applications against job‑related criteria and/or transferrable skills. These tools help ensure a consistent, structured evaluation, but they do not make hiring decisions. All decisions involve a human reviewer. For more information on how we handle personal data, please see our Elanco Workforce Privacy Notice.