Regulatory Affairs Manager

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!

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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

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