Virbac→
Sr. Regulatory Affairs Specialist at Virbac in Taipei City, Taiwan
Job Description
Sr. Regulatory Affairs Specialist
Location: Taipei City, Taiwan
Experiencing together a unique human adventure
Animal health is key to the health of the planet. Working at Virbac means taking part in a unique human adventure in which the engagement of each individual contributes to its evolution. Encouraging internal mobility between positions and countries, offering individual development plans and building a partnership based on trust between managers and employees are as many perspectives of motivation for our teams. We also offer them a work environment conducive to exploring new territories and balancing their professional and personal lives. Finally, fostering their engagement to animal health also means listening to them and helping them to acquire new skills, preparing them for the challenges of tomorrow and encouraging them to contribute to an ever more responsible approach to our business.
1.New Registration & RA Compliance NRA (national RA) role:
• Responsible for the preparation, dossier review, and submission for new product registrations, act as national RA in Taiwan.
• Ensure 100% regulatory compliance for import release, packaging text (artwork/labels), and local promotional/social media materials.
• Up to Oct 2026: 48 valid import MAs from 6 sites; 30 valid manufacture MAs locally.
2.Kaohsiung Site Biological LCM (Export Markets) MRA role:
• Collaborate closely with Export countries NRA and manufacturing teams to manage product registration and life cycle management (LCM) for biologicals produced at the Kaohsiung site (e.g., PCV2) across key export markets in Asia (4 countries) and Latin America (8 countries), act as manufacturing RA (MRA), communicate in English.
• Up to Oct 2026: 12 oversea MAs for Kaohsiung site.
3, Regional & Partner RA Coordination:
• Act as the key RA hub bridging communications between MRA, cross-functional teams, and external partners.
• Coordinate registration and variation projects with export countries (e.g., Indonesia and Malaysia) local distributor RA and licensing partners (3rd parties), ensuring alignment on dossier gaps, submission timelines, and strategy execution.
• Up to Oct 2026: 4 oversea MAs for licensing partners; 28 oversea MAs for export countries.
4.Petcare Portfolio Regulatory:
• Provide regulatory and technical guidance for Petcare and nutritional healthcare products, evaluating technical changes, product claims, and regulatory feasibility to support marketing initiatives and product launches.
5.Operational Excellence & Stock Transfer Management:
• Lead cross-border Stock Transfer regulatory evaluations and standardized tracking (supporting affiliate inventory stability).
• Drive continuous improvement by establishing, updating, and standardizing core SOP frameworks, tracking systems, and digital/AI tools to optimize regulatory workflows and submission quality.
A Senior Technician applies advanced practical knowledge of job area typically obtained through short cycle education and work experience. Responsibilities may include: • Work is closely supervised. • Problems are typically of a standard nature, but may at times require interpretation. • Explains facts, policies and practices related to job area.