Regulatory Affairs Supervisor

About the role

The Regulatory Affairs Supervisor will lead the preparation and submission of regulatory dossiers to obtain and maintain marketing authorisations for AbbVie products in Taiwan. The role ensures compliance with local regulations, supports product launches, and provides regulatory guidance to internal teams and external partners.

Key responsibilities

• Manage registration of new products and variations, ensuring approvals align with company objectives and timelines.
• Coordinate responses to deficiency letters and data requests from regulatory authorities.
• Liaise with government officials to facilitate evaluation processes and provide required information.
• Update product labeling based on headquarters’ changes and ensure compliance with relevant codes.
• Generate registration plans, produce regular status reports, and communicate progress to management.
• Assess regulatory issues, evaluate business impact, and advise senior leadership.
• Maintain up‑to‑date knowledge of corporate policies and local regulations, communicating changes promptly.
• Update and review RA SOPs, and contribute to process improvements to increase productivity.

Required profile

• Strong knowledge of Taiwanese pharmaceutical regulations and corporate compliance policies.
• Experience preparing and managing regulatory submissions for pharmaceutical products.
• Ability to communicate regulatory matters clearly to senior management and cross‑functional teams.
• Proactive approach to monitoring regulatory changes and implementing necessary updates.

Required skills