RBW Consulting are proud to be partnered with an industry leading, mid-sized global CRO that cover multiple therapeutic areas but have particularly strong focuses on Oncology and Rare Diseases. Due to the recent award of new studies this CRO are currently seeking a Freelance Regulatory Submissions Associate based in South Korea to join their team.
The Freelance Regulatory Submissions Associate assumes regulatory responsibilities including initial and subsequent Clinical Trial submissions to Competent Authority (CA) and Ethics Committees (ECs) / Institutional Review Board in South Korea and ensure compliance with local and international clinical trials regulations and guidelines.
- Provide support to Global/Regional Regulatory Lead for assigned studies and may on occasion be requested to act as Regional Regulatory Lead across the APAC.
- Preparation of Clinical Trial Application Forms (Country EudraCT form for EEA countries and/or National Application Form)
- Preparation of submission dossier (initial and amendments/notifications) for submission to CA, EC and other applicable local bodies according to local requirements and within required timelines to obtain all necessary authorisations/approvals for the conduct of the Clinical Trial.
- Interaction with CA/EC for study purposes and handling responses to the CA/EC. Providing CA/ EC related information as applicable.
- Providing regular updates about CA and EC submissions to Regulatory Lead assigned to the study and to Project Manager/Project Team as relevant.
- Provide support for other Regulatory submission documents (MAA/NDA, ODD, PIP, Scientific Advice), as requested, including support for Health Authority Meetings.
- Submit expedited reports including SUSARs, and periodic updates to the CA/EC and other applicable local bodies according according to local requirements and within required timelines.
- Submit applications for drug and laboratory kit importation and exportation to applicable local bodies according according to local requirements and within required timelines.
- Provide advice to the Regulatory Lead regarding labelling of investigational products according to local requirements.
- Submit at least annual reports to the EC according to local requirements.
- Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership updated.
- Keep an updated knowledge of the local clinical trial laws, regulations and guidelines.
- Participating in regulatory activities within the company and ensuring regulatory (CA and EC) related activities are performed according to international and local/national applicable regulations, company SOPs and principles of ICH-GCP.
- 2+ years regulatory experience minimum.
- Specialised knowledge of regulatory activities including but not limited to regulatory submissions to HAs and ECs.
- Registered with MFDS to submit CTA as "CTA Holder/Local Sponsor".
- Knowledge and expertise in GCP/ICH guidelines and applicable country regulations.
- Fluency in English
Please apply here and Harry Henson will be in contact to discuss your application further.
must be ltd comapny
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