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Regulatory Affairs Specialist - Thailand

External
elanco logoElanco · Thailand
Full-timeOn-site1d ago
ComplianceDocumentationLess
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Responsibilities

  • Manage end-to-end regulatory activities including initial registrations, variations, renewals, and Marketing Authorization Transfers for the Thailand market.
  • Maintain the Global Regulatory database and internal documentation systems to ensure all product licenses and legal records are accurate and up-to-date.
  • Partner with cross-functional teams (Supply Chain, Quality, Marketing) and external regulatory agencies to support business objectives and shape the regulatory environment.
  • Oversee Pharmacovigilance activities by monitoring adverse events and ensuring timely submission of drug safety reports per Elanco SOPs and local laws.
  • Review and approve promotional, educational, and artwork materials to ensure full regulatory compliance and brand protection.
  • What You Need to Succeed (minimum qualifications):
  • Education: Bachelor's Degree in Pharmacy
  • Experience: A minimum of 3 years of experience in regulatory affairs
  • Proficiency in Thai and English (written/spoken) and strong organizational skills for managing sensitive information.
  • What will give you a competitive edge (preferred qualifications):
  • Ability to network effectively across diverse groups and organizational levels.
  • Proven experience managing multiple projects simultaneously while meeting strict deadlines.
  • High learning agility with the ability to prioritize work effectively in a fast-paced environment.
  • Experience with artwork management systems (e.g., BLUE system).
  • Strong interpersonal skills with a focus on follow-through and problem resolution.
  • Additional Information:
  • Location: Bangkok, Thailand - [insert work model]
  • #LI-EG2
  • 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

Benefits

Health insuranceVision insurance

Additional Information

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 Specialist As a Regulatory Affairs Specialist, you will be part of the Thailand Regulatory team to deliver product registrations, variation filings, and technical transfers. In this role, you'll be responsible for maintaining licenses, updating global regulatory databases, and ensuring compliance with local and international safety requirements.


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