Regulatory Affairs Manager, I&I Alliance

Location: Beijing, China

Company

hirify.global develops medicines and healthcare solutions focused on improving patient outcomes and advancing pharmaceutical science.

What you will do

• Develop and implement regulatory strategies for Immunology & Inflammation Alliance products in China.
• Lead cross-functional submission teams through Marketing Authorisation applications and lifecycle management activities.
• Manage regulatory processes, dossier quality, and compliance with NMPA requirements and internal standards.
• Evaluate regulatory pathways, risks, and timelines for assigned products.
• Coordinate regulatory activities with the China Business Unit, global divisions, and Global Regulatory Affairs teams.
• Monitor regulatory changes, communicate their impact, and anticipate future requirements.

Requirements

• Bachelor’s degree in Pharmacy, Medicine, Life Sciences, or a related field; a Master’s degree or above is preferred.
• At least 8 years of regulatory affairs experience in the pharmaceutical industry.
• Solid experience with regulatory submissions in China.
• Proficiency in both Chinese and English, including fluent written and spoken communication.
• Strong project management and cross-functional coordination skills.
• Good understanding of NMPA requirements and global regulatory frameworks; ability to lead submission teams without direct authority.

Culture & Benefits

• Equal-opportunity workplace supporting people from diverse backgrounds and locations.
• Focus on progress, better medications, improved outcomes, and advancing science.
• Collaboration across China-based business teams and global divisions.