Regulatory Affairs Manager

• Lead regulatory strategy for innovative pharmaceutical products.
• Manage a regulatory team and drive key product approval projects.

About Our Client Our client is a leading global pharmaceutical company dedicated to developing and commercialising innovative medicines that address significant unmet medical needs. With a strong global presence and diverse pipeline, the organisation continues to deliver impactful healthcare solutions worldwide.

Job Description

• Lead regulatory submissions for new products and post-approval variations in Taiwan
• Ensure timely approval and maintenance of product registrations in line with business objectives
• Develop and execute regulatory strategies to support product launches and lifecycle management
• Manage interactions with health authorities and facilitate review and approval processes
• Coordinate and oversee responses to regulatory inquiries and deficiency letters
• Review product labelling, prescribing information, and related documents to ensure regulatory compliance
• Lead cross-functional discussions and provide regulatory guidance to business stakeholders
• Support regulatory planning for new product introductions and pipeline development projects
• Monitor regulatory developments and assess potential business impact
• Maintain and improve regulatory procedures, policies, and SOPs
• Lead regulatory projects and provide progress updates to local and global stakeholders
• Manage team performance and support capability development within the Regulatory Affairs function

The Successful Applicant Required Qualifications

• Bachelor's degree or above in Pharmacy, Pharmacology, Biology, or a related discipline
• Approximately 8 years or more of Regulatory Affairs experience within the pharmaceutical industry in Taiwan
• Strong knowledge of Taiwan pharmaceutical regulations and registration requirements
• Proven experience managing regulatory submissions and product lifecycle activities
• Strong communication, stakeholder management, and project coordination skills
• Ability to communicate strategic and operational issues effectively to senior management
• Fluent English communication skills, both written and spoken

Preferred Qualifications

• Experience with New Chemical Entity (NCE) submissions
• Knowledge of clinical development and regulatory requirements
• Experience within a multinational pharmaceutical environment
• Demonstrated experience in regulatory strategy development and product launches

What's on Offer

• Opportunity to lead regulatory strategy for a diverse pharmaceutical portfolio
• Exposure to product launches and pipeline development projects
• Close collaboration with regional and global stakeholders
• Leadership responsibility within a multinational pharmaceutical organisation
• Additional compensation and benefits details: To be confirmed

Quote job ref: JN-102026-7125643