Global Clinical Regulatory Lead – Trials & Dossiers

CANSINO BIOLOGICS (HONG KONG) LIMITED; Hong Kong; Presencial; HKD 700.000 - 1.100.000; Jornada completa

Descripción de la vacante

CANSINO BIOLOGICS (HONG KONG) LIMITED is hiring a regulatory affairs expert to shape drug development strategies, DS/DP development, and study design in collaboration with HK authorities. You will liaise with the Hong Kong Department of Health and overseas agencies (EMA, FDA), draft registration dossiers, and align R&D plans with regulatory expectations.

Coordinate with R&D, manufacturing, quality and external partners to drive timely submissions and regulatory approvals for Hong Kong and global

Formación

• Master's degree or above in Biology, Pharmacy, Medicine, or related fields.
• ≥3 years' experience in drug R&D, preclinical studies, or clinical trial applications.
• Excellent communication and teamwork; proactive problem-solving and adaptability.

Responsabilidades

• Review research data across the full chain biopharmaceutical tech development and plan DS/DP development.
• Engage with HK Department of Health, regulatory authorities, and partners; support product approvals and launches.
• Lead technical work for clinical trial applications and overseas regulatory filings (EMA/FDA).
• Coordinate clinical trial activities in HK and manage cross-border import and sample control.
• Develop regulatory plans and track progress to ensure timely approvals.

Conocimientos

Master's degree or above

Drug R&D experience

Communication & teamwork

Self-directed learning

Attention to detail & compliance

Educación

Master's degree or above in Biology, Pharmacy, Medicine, or related fields

Descripción del empleo

CANSINO BIOLOGICS (HONG KONG) LIMITED is hiring a regulatory affairs expert to shape drug development strategies, DS/DP development, and study design in collaboration with HK authorities. You will liaise with the Hong Kong Department of Health and overseas agencies (EMA, FDA), draft registration dossiers, and align R&D plans with regulatory expectations.

Coordinate with R&D, manufacturing, quality and external partners to drive timely submissions and regulatory approvals for Hong Kong and global