Director, Regulatory Affairs - Biotech Platform

Company Overview

The client is a venture-capital backed biotechnology platform based in Singapore, specializing in acquiring and developing promising therapeutic assets for worldwide advancement. The organization serves as a strategic link across regions including the US and Asia, advancing programs through crucial clinical and regulatory phases.

Supported by a top-tier global life sciences investor experienced in building successful biotech companies, the company operates with a lean model leveraging external collaborators and CROs. With an expanding pipeline and plans for global clinical trials starting in 2027, they are entering a critical growth phase and expanding their leadership team accordingly.

Role Responsibilities

• Lead the creation and execution of comprehensive global regulatory strategies for pipeline assets.
• Take charge of US IND submissions and maintain direct communications with the FDA and other health authorities.
• Oversee daily regulatory operations and ensure timely submissions.
• Collaborate cross-functionally to harmonize regulatory strategies with clinical development goals.
• Manage relationships with external CROs, consultants, and international regulatory partners.
• Contribute to due diligence processes and regulatory evaluations for in-licensing opportunities.
• Ensure adherence to regulatory compliance, implement risk mitigation tactics, and maintain readiness for inspections across programs.

Candidate Profile

• More than 10 years of regulatory affairs experience in the biotech or pharmaceutical sectors.
• Established success managing IND submissions and liaising with the FDA.
• Expertise in global regulatory strategy involving multiple geographic regions.
• Experience working within lean or early-stage biotech company settings.
• Ability to operate effectively both at a strategic leadership level and in hands-on regulatory tasks.
• Proven capability in managing CROs and external regulatory partners.
• Experience supporting international cross-border development initiatives.

What This Role Offers

This position provides the opportunity to join a high-potential biotech platform during a pivotal development period. The role grants substantial ownership, frequent interaction with senior leadership, and the ability to architect regulatory strategies from the foundation up. The work environment is collaborative and entrepreneurial, bolstered by strong investor support, and includes a competitive compensation package along with prospects for long-term value creation.