Regional Regulatory Affairs Lead – Asia (Biologics MNC)

Charterhouse Pte Ltd; Singapore; On-site; SGD 90,000 - 130,000; Full time

Job summary

A leading multinational company in the biologics sector is seeking a Regional Regulatory Affairs Lead to shape regulatory strategies across Asia. The ideal candidate has an advanced degree and a minimum of 6 years of experience in regulatory affairs, with strong knowledge of biologics requirements. This high-impact role requires excellent communication skills and project management capabilities. Interested candidates should email their resumes for a confidential discussion.

Qualifications

• Minimum 6 years of experience in regulatory affairs with multi-market coverage.
• Strong knowledge of country-specific regulatory requirements in Asia.
• Familiarity with electronic regulatory systems and databases.

Responsibilities

• Lead and support regulatory submissions across Asia.
• Act as the primary liaison between global regulatory affairs and health authorities.
• Monitor regulatory changes and provide updates to global teams.
• Collaborate with internal cross-functional teams.
• Support product lifecycle management and strategic regulatory planning.

Skills

Knowledge of regulatory requirements for biologics or pharmaceuticals

Project management capabilities

Excellent communication skills in English

Collaborative mindset

Education

Advanced degree in life sciences or related field

Tools

Electronic regulatory systems

Job description

Coverage: Asia Region

Industry: Biologics / Specialty Pharmaceuticals

Our client is a leading multinational company in the biologics sector, committed to improving patients’ lives through high-quality, innovative therapies. With a strong global footprint and a pipeline of specialty products, they are now seeking a Regional Regulatory Affairs Lead to join their growing team.

In this regional role, you will play a pivotal part in shaping regulatory strategies and ensuring successful product registrations across the Asia region. You’ll act as the key link between global regulatory affairs, local partners, and health authorities - helping to bring life-changing products to market efficiently and compliantly.

Key Responsibilities:

• Lead and support regulatory submissions across the Asia region, ensuring full compliance with local and country-specific requirements

• Serve as the primary liaison between global regulatory affairs, in-country partners, and health authorities

• Monitor regulatory changes in the region and provide timely updates to global teams

• Collaborate closely with internal cross-functional teams including country managers, QA, and medical affairs

• Support product lifecycle management and contribute to strategic regulatory planning

• Maintain and update internal regulatory databases and systems

• Facilitate effective communication and alignment with local agents and authorities

Travel Requirements:

• Occasional travel to meet with health authorities, local regulatory partners, or attend key international regulatory events and conferences

What We’re Looking For:

• Advanced degree in life sciences, regulatory affairs, pharmacy, or a related field

• Minimum 6 years of experience in regulatory affairs roles, with proven multi-market coverage in Asia

• Strong knowledge of country-specific regulatory requirements for biologics or pharmaceuticals

• Familiarity with electronic regulatory systems and databases

• Excellent written and verbal communication skills in English

• Strong project management capabilities and a collaborative, solution-oriented mindset

This is a high-impact role ideal for someone who thrives in a global matrix setting, is passionate about regulatory science, and wants to contribute to meaningful healthcare outcomes across diverse markets.

Please email your resume to Mervin Chai at [e-mail] for a confidential discussion.

EA License no: 16S8066 | Reg no.: R1104272

Only successful candidates will be notified.