Clinical Regulatory

CANSINO BIOLOGICS (HONG KONG) LIMITED; Hong Kong; On-site; HKD 700,000 - 1,100,000; Full time

Job summary

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

Qualifications

• 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.

Responsibilities

• 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.

Skills

Master's degree or above

Drug R&D experience

Communication & teamwork

Self-directed learning

Attention to detail & compliance

Education

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

Job description

• Review the research data atstage of the full chain biopharmaceutical technology development, conduct pre-IND discussion and provide development strategy on DS and DP development, including process development, analytical methods and specification determination. Conduct nonclinical and clinical design for studies including toxicology and pharmacology, clinical trial design andtechnical problem solving and related fields.
• Focus on engaging with the Hong Kong Department of Health, overseas regulatory authorities, and collaborative partners. The role supports the substantive operation of biomedical R&D projects, providing technical R&D outputs to facilitate the company's product approvals and market launches in Hong Kong and globally.Track regulatory updates from Hong Kong and global health authorities; conduct regulatory gap analysis and internal R&D compliance training; maintain full-lifecycle management of product registration technical dossiers, supporting the stable operation of local Hong Kong R&D projects.
• Responsible for the technical work of clinical trial applications and marketing registration for the company's products with the Hong Kong Department of Health, as well as overseas regulatory agencies such as EMA and FDA. Lead the drafting of registration dossiers, module integration, data compilation, and review of technical protocols and reports; guide the modification and optimization of R&D strategies.
• Participate in liaising with local Hong Kong clinical trial institutions, ethics submissions, and compliant management of trial material circulation; drive the implementation of clinical trials in Hong Kong. Oversee the compliant cross-border import management of R&D clinical batches, reference samples, and stability retention samples.

Responsible for the management of clinical trial projects; develop regulatory plans and drive their implementation to ensure on-time project completion; coordinate resources across R&D, manufacturing, quality, clinical, and external partners to ensure smooth project progression; track clinical approval progress, provide timely feedback on regulatory agency opinions, and organize internal responses; identify project risks and propose solutions to ensure the feasibility and compliance of registration pathways.

Requirements

• 1. Master's degree or above in Biology, Pharmacy, Medicine, or related fields.
• 2.Three years of experience in drug research and development, preclinical studies conducting, clinical trial application or related fields is preferred.
• 3. Excellent communication and teamwork skills, with the ability to collaborate effectively with team members and other departments.
• 4. Ability for self-directed learning and problem-solving, with adaptability to new technologies and methodologies.
• 5. Rigorous work attitude, with attention to detail and compliance in operational processes.

• Review the research data atstage of the full chain biopharmaceutical technology development, conduct pre-IND discussion and provide development strategy on DS and DP development, including process development, analytical methods and specification determination. Conduct nonclinical and clinical design for studies including toxicology and pharmacology, clinical trial design andtechnical problem solving and related fields.
• Focus on engaging with the Hong Kong Department of Health, overseas regulatory authorities, and collaborative partners. The role supports the substantive operation of biomedical R&D projects, providing technical R&D outputs to facilitate the company's product approvals and market launches in Hong Kong and globally.Track regulatory updates from Hong Kong and global health authorities; conduct regulatory gap analysis and internal R&D compliance training; maintain full-lifecycle management of product registration technical dossiers, supporting the stable operation of local Hong Kong R&D projects.
• Responsible for the technical work of clinical trial applications and marketing registration for the company's products with the Hong Kong Department of Health, as well as overseas regulatory agencies such as EMA and FDA. Lead the drafting of registration dossiers, module integration, data compilation, and review of technical protocols and reports; guide the modification and optimization of R&D strategies.
• Participate in liaising with local Hong Kong clinical trial institutions, ethics submissions, and compliant management of trial material circulation; drive the implementation of clinical trials in Hong Kong. Oversee the compliant cross-border import management of R&D clinical batches, reference samples, and stability retention samples.

Responsible for the management of clinical trial projects; develop regulatory plans and drive their implementation to ensure on-time project completion; coordinate resources across R&D, manufacturing, quality, clinical, and external partners to ensure smooth project progression; track clinical approval progress, provide timely feedback on regulatory agency opinions, and organize internal responses; identify project risks and propose solutions to ensure the feasibility and compliance of registration pathways.

Requirements

• 1. Master's degree or above in Biology, Pharmacy, Medicine, or related fields.
• 2.Three years of experience in drug research and development, preclinical studies conducting, clinical trial application or related fields is preferred.
• 3. Excellent communication and teamwork skills, with the ability to collaborate effectively with team members and other departments.
• 4. Ability for self-directed learning and problem-solving, with adaptability to new technologies and methodologies.
• 5. Rigorous work attitude, with attention to detail and compliance in operational processes.