Job Title: Senior Regulatory Affairs Manager
Location: Taipei, Taiwan
Job Type: Full-time
Company: Elanco Animal Health
Requisition ID: R0022503
Estimated Salary: NT$1,400,000–NT$2,000,000 per annum (based on industry benchmarks and seniority)
Overview:
Elanco is seeking a Senior Regulatory Affairs Manager to lead regulatory strategy and operations in Taiwan. The role focuses on managing product registrations, license renewals, variations, and regulatory compliance in accordance with local laws and Elanco's internal SOPs. This senior-level position offers a strategic opportunity to contribute to Elanco’s regulatory excellence in animal health, while also acting as the local PV Responsible (LPVR) for pharmacovigilance.
Key Responsibilities:
Regulatory Operations & Compliance:
Independently manage new product registrations and existing license renewals/variations
Oversee site changes and marketing authorization transfers
Compile and submit regulatory dossiers, packaging materials, and inserts
Act as the final approver for promotional materials
Stay updated with evolving regulatory laws and inform relevant stakeholders
Maintain complete and accurate documentation of regulatory submissions
Cross-Functional Collaboration:
Coordinate with global, regional, and affiliate-level teams (R&D, Regulatory, CMC, Quality)
Provide local regulatory insights to global development teams
Assist in post-marketing studies and quality procedures linked to RA
Support regulatory strategy development and SOP reviews
Pharmacovigilance & Quality Support:
Serve as Taiwan’s Local PV Responsible (LPVR) to ensure pharmacovigilance compliance
Collaborate with Global PV to meet affiliate standards
Engage in quality assurance tasks related to RA compliance
Required Qualifications:
Bachelor’s degree or higher in Veterinary Medicine, Animal Science, Pharmaceutical, or Chemical/Biopharmaceutical Sciences
Minimum 6 years of regulatory affairs experience in the veterinary or pharma industry
Proven expertise in local regulatory procedures and government relations
Excellent English communication skills (verbal and written)
Strong project management, strategic thinking, and leadership skills
Familiarity with Microsoft Office Suite and documentation systems
Preferred Qualifications:
Strategic mindset with the ability to work independently
Experience contributing to or leading regulatory SOP development
Prior success in cross-functional collaboration with global teams
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