In Vivo Scientist: Preclinical & Regulatory Leader

TAIKANGNUO BIOTECHNOLOGY LIMITED; Hong Kong; On-site; HKD 600,000 - 900,000; Full time

Job summary

TAIKANGNUO BIOTECHNOLOGY LIMITED in Hong Kong is seeking a skilled researcher to design and execute GLP/ISO-compliant experiments, lead preclinical study planning, and ensure regulatory compliance across programs. You will collaborate with pharmacology and toxicology teams to advance IND/NDA initiatives and maintain accreditation standards.

The role emphasizes data integrity, ethical animal research oversight, and staying current with global guidelines and literature to drive project timelines.

Qualifications

• Experience with GLP/ISO standards and regulatory frameworks.
• Ability to design and interpret preclinical studies for drugs and devices.
• Proficient data collection, analysis, and documentation practices.
• Familiarity with laboratory accreditation and compliance processes.

Responsibilities

• Design and execute GLP/ISO-compliant research programs.
• Lead preclinical study protocol design for drugs/medical devices.
• Maintain accreditation and ensure regulatory compliance.
• Review trials per FDA/ICH/NMPA guidelines and prepare registrations.
• Collect and analyze data with GraphPad, SPSS, and LabArchives.
• Record data and produce raw reports and summaries.
• Oversee animal study planning and welfare.
• Coordinate cross-department updates and risk mitigation.
• Collaborate with pharmacology and toxicology teams on IND/NDA dossiers.
• Stay updated on scientific literature and ethical review processes.

Skills

GLP compliance

Regulatory knowledge

Data analysis

Animal handling

Cross-functional collaboration

Tools

GraphPad

SPSS

LabArchives

Job description

TAIKANGNUO BIOTECHNOLOGY LIMITED in Hong Kong is seeking a skilled researcher to design and execute GLP/ISO-compliant experiments, lead preclinical study planning, and ensure regulatory compliance across programs. You will collaborate with pharmacology and toxicology teams to advance IND/NDA initiatives and maintain accreditation standards.

The role emphasizes data integrity, ethical animal research oversight, and staying current with global guidelines and literature to drive project timelines.