Scientist / Senior Scientist, RNA Analytical Development
You are an analytical development scientist with deep expertise in RNA modalities, someone who thrives at the intersection of method development, platform scalability, and translational impact. You want to build analytical systems that become the backbone of an entire RNA therapeutics engine.
This organisation is building a biotech‑like translational engine designed to take novel oligo, mRNA, and conjugate programs from discovery into the clinic. Modern labs, new equipment, and a rapidly scaling team mean your analytical leadership will shape how the entire platform operates.
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Regulatory Submissions & Change Notification Governance: Coordinate and track timely submissions for product registrations, renewals, and variations across Asia. Own the end-to-end process for regulatory change notifications, ensuring impact assessments, documentation readiness, and submission tracking in partnership with country RAQA and global teams.
Regulatory Intelligence, Labelling & UDI Compliance: With the support of local RAQA, monitor evolving Asia regulations and provide strategic insights on labelling and UDI requirements. Support impact assessments, update SOPs/templates, and disseminate regulatory intelligence to country teams to ensure compliance and traceability.
Complaint Handling, FSCA & Recall Execution: Lead regional coordination of complaint intake, triage, and resolution. Manage FSCA and recall processes, ensuring timely execution, regulatory reporting, and effective field actions in collaboration with Quality, Supply Chain, and Commercial teams.
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Auditing: Supports the planning and execution of plant quality system audits by conducting compliance assessments and providing recommendations and guidance to ensure applicable quality and regulatory standards are met. Prepares audit summaries, tracks corrective action implementation, and provides regular progress updates to the Associate Manager, QRC.
Documentations: Reviews plant compliance against global procedures, policies, and standards, identifies gaps, and supports the implementation and follow up of corrective actions. Supports risk assessment verification and navigation activities to ensure effective risk control and compliance outcomes.
Training: Supports the development and delivery of training programs related to regulatory, religious, and quality requirements, and conducts and coordinates QA training programs to ensure plant personnel are adequately trained and compliant with applicable standards.
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Own functional testing for platform products, including test planning, test design, execution, and quality assurance for releases.
Perform API testing and understand the overall service invocation flow, including upstream/downstream dependencies across long and complex backend chains.
Design and execute end-to-end test scenarios covering frontend, backend, strategy, and algorithm-driven interactions.
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Build and maintain strong relationships with key e-commerce platforms (TikTok) and other Digital partners
Negotiate and manage partnership agreements to ensure mutual benefits and alignment with Samsung's business goals
Manage both 1P (Retail) and 3PD (Marketplace) business models effectively, ensuring seamless integration and optimization of both channels to maximize sales and customer satisfaction
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