Senior Director, Regulatory Affairs – Taiwan

About the role

The company is seeking a senior leader to shape and drive global regulatory strategies for innovative therapies in Taiwan. This role will guide regulatory planning, submission preparation and cross‑functional collaboration to ensure successful interactions with health authorities worldwide.

Key responsibilities

• Develop and implement global regulatory strategies supporting product development, clinical trials and market approvals.
• Provide regulatory guidance to cross‑functional teams, aligning with overall business objectives.
• Lead the planning, preparation, authoring and review of submissions to agencies such as FDA, EMA and other international regulators.
• Manage regulatory submissions across the product lifecycle, including INDs, CTAs, NDAs, BLAs and MAAs.
• Ensure all regulatory documentation is accurate, complete, compliant and delivered on schedule.
• Monitor deliverables, identify risks and implement mitigation plans to protect timelines.
• Collaborate with external vendors and regulatory operations on submission planning, publishing and document management.
• Drive continuous improvement of regulatory processes, standards and workflows.

Required profile

• Bachelor’s degree required; Master’s degree in a life‑science discipline preferred.
• Minimum 7 years of experience in drug development and regulatory affairs.
• Proven experience preparing regulatory submission documents for global health authorities.

Required skills