全职 Subject Matter Expert 工作, 薪水, Apsida Life Science 公司招聘中 - Ricebowl

Title: (RA/SME) - Drug-Device Combination Products

Location: Singapore – Fully remote

Duration: 6-12 months

Commitment: 160 hours per month

Company Overview

Apsida Life Science is currently partnering with an organisation dedicated to community-based clinical trials, ensuring excellent standards of participant care and a smooth transition from the hospital to the home in accordance with study protocols, clinical practice regulations, and ICH-GCP requirements.

Responsibilities:

• Review technical documentation and regulatory dossiers to support product evaluation.
• Address the client's core concern regarding whether IBI306 will be classified and regulated as a drug-device combination product by the Health Sciences Authority (HSA) in Singapore.
• Conduct a comprehensive gap analysis covering technical questions related to CMC (Chemistry, Manufacturing, and Controls) and medical device integration.
• Collaborate with internal teams to evaluate manpower considerations and resource planning for regulatory submissions.
• Participate in discussions and meetings with the client to explain regulatory pathways, potential deficiency questions, and strategic recommendations.

Qualifications:

• Bachelor’s Degree in Life Science or equivalent
• Deep professional background spanning Chemistry, Manufacturing, and Controls (CMC) alongside medical device regulations or combination product evaluation.
• Familiarity with biologic products, monoclonal antibodies, and combination delivery systems (e.g., pre-filled autoinjectors).
• Strong stakeholder management skills to guide clients through complex regulatory uncertainties and technical gap analyses.

If you are interested in learning more, please reach out to Sweetness Zono at Apsida Life Science:

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Apsida Life Science is a specialist recruitment business based in London (UK), Redhill (UK), Boston (USA) & Pretoria (South Africa) that is dedicated to delivering the best talent to the Life Science industry. We believe there is a gap in the market for a cost-effective, high-quality, and trusted recruitment service that puts the candidate journey at the heart of the recruitment process