Regulatory Affairs Manager

Contact: Alvin Yeo Zong Han (Lic No: R24126316 / EA No: 16S8194)

Quote Job Ref:

Phone Number: +65 6027 2671

Job Advertisement: Regulatory Affairs Manager

Location: Hong Kong

About:

Our client is a fast-growing biotechnology company specializing in active collagen with leading capabilities across medical aesthetics, pharmaceuticals, and healthcare. With a strong presence across Greater China and an expanding international footprint, the company is building its Hong Kong hub to drive regional growth and regulatory excellence.

Overview:

This is a high-impact, cross-functional position that will play a critical role in driving regulatory strategy, managing product registration and lifecycle processes, and coordinating cross-border activities between Hong Kong and Shanghai HQ.

Beyond regulatory work, this role requires a project management and coordination mindset, working closely with commercial, medical, and operational teams to enable market expansion.

Key Responsibilities:

• Lead and manage regulatory submissions, product registration, and lifecycle management across Hong Kong and regional markets
• Act as the key coordination point between Hong Kong and Shanghai HQ (CEO, CMO, and RA teams)
• Drive regulatory strategy and execution to support both medical aesthetics and pharmaceutical portfolios
• Manage product renewals, variations, and compliance processes in a timely manner
• Support in-licensing and product introduction activities, including working with global partners
• Collaborate cross-functionally with commercial, medical, marketing, and supply chain teams
• Ensure compliance with relevant local and regional regulatory requirements
• Support broader business operations and project management initiatives as the Hong Kong hub scales

Key Requirements:

• 8-15 years of experience within Regulatory Affairs/Healthcare/Pharmaceuticals
• Experience managing regional or cross-border regulatory processes is strongly preferred
• Exposure in one or more of the following: Regulatory Affairs (preferred)/Pharmaceuticals/Biopharma/Medical Aesthetics/Medical Devices
• Experience supporting product registration, market access, or licensing activities
• Strong project management and coordination skills (critical requirement)
• Ability to work across multiple stakeholders in different geographies
• Hands-on, adaptable, and comfortable operating in a fast-paced, evolving environment
• Entrepreneurial mindset with willingness to take on broad responsibilities beyond RA
• Strong communication skills in Mandarin and English (mandatory)
• Willingness to travel across China and Southeast Asia
• Open to being based in Hong Kong (relocation support available)

If you are interested in this role, please apply with your most updated CV attached.

Contact: Alvin Yeo Zong Han (Lic No: R24126316 / EA No: 16S8194)