Researcher

Cytopeutics Sdn Bhd; Sepang; On-site; MYR 40,000 - 60,000; Full time

Job summary

A biotechnology company located in Sepang, Malaysia, is seeking a dedicated professional to support product development and ensure regulatory compliance. This role involves coordinating clinical studies and preparing necessary documentation for international projects. Ideal candidates will have a Bachelor's degree in a related field and a minimum of 2 years of relevant experience. Strong interpersonal skills and the ability to manage multiple tasks are essential. A five-day work week and an attractive remuneration package are offered.

Benefits

Five-day work week

Attractive remuneration package

Qualifications

• Minimum 2 years of experience in biomedical or clinical research.
• Basic knowledge of clinical trial processes would be an advantage.
• Mandarin-speaking candidates preferred for China project communication.

Responsibilities

• Support product development and regulatory readiness.
• Assist in planning and execution of clinical studies.
• Prepare documents for international research projects.
• Analyze data and prepare reports for submissions.
• Coordinate with internal teams and external partners.

Skills

Biomedical research

Regulatory affairs

Cell culture techniques

Molecular techniques

Microsoft Office

SPSS

Good Laboratory Practice (GLP)

Good Manufacturing Practice (GMP)

Education

Bachelor’s Degree in Biotechnology or related field

Job description

• Support, coordinate, and monitor activities related to product development and regulatory readiness, including compliance with global standards (e.g., China NMPA, US FDA, etc.).
• Assist in planning and execution of preclinical and clinical studies, ensuring alignment with regulatory guidelines and product development milestones.
• Prepare and review documents required for international research projects and product registration, ensuring accuracy and compliance with country-specific guidelines.
• Manage project timelines, deliverables, and documentation to ensure smooth execution of preclinical and clinical development plans.
• Coordinate communications with internal teams and external partners (regulatory consultants, CROs, laboratories) to support clinical translation and market entry.
• Support translation or interpretation of technical documents (where applicable) for effective cross‐border collaboration.
• Analyze experimental or clinical data and prepare technical reports for internal review and regulatory submissions.
• Provide administrative and technical support for research and regulatory projects.
• Any other tasks as and when requested by the Management.

DESIRED SKILLS & EXPERIENCE

• Bachelor’s Degree in Biotechnology, Life Science, Medical Science, Pharmacy or a healthcare discipline is preferred.
• Minimum 2 years of related working experience in biomedical research, clinical research, regulatory affairs, or biotechnology product development. Fresh graduates with strong potential are also encouraged to apply.
• Knowledge of NMPA (China) guidelines, or experience working with China-based regulatory or research partners, is a strong plus.
• Hands‑on experience with cell culture techniques (primary cells or stem cells) or molecular techniques (e.g. flow cytometry, PCR).
• Basic understanding of Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP).
• Willingness to occasionally work outside of standard hours to support time‑sensitive tasks beyond regular working hours when required to accommodate international partner schedules.
• Computer literate with good knowledge of Microsoft Office applications and preferably proficient in SPSS software as well.
• Candidates with basic knowledge of clinical research/trial processes and International Council for Harmonisation (ICH) and/or Good Clinical Practice (GCP) guidelines would have an added advantage.
• Responsible, committed, has initiative and result oriented.
• An individual who takes pride in his/her work, self‑motivated and a team player.
• Good interpersonal and communications skills.
• Mandarin‑speaking candidates are highly preferred to support China‑related project communication.
• Excellent organizational and project management skills including ability to work on multiple activities concurrently prioritise tasks and meet competing deadlines.

We offer a FIVE-DAY WORK WEEK & attractive remuneration package to commensurate with qualification and experience to successful candidates.

Only shortlisted candidates will be notified.