台灣微脂體股份有限公司

We are seeking a Clinical Operations Coordinator to oversee the planning and execution of clinical studies in compliance with GCP/ICH guidelines and company SOPs. This role serves as the primary contact for clinical trial operations and manages day-to-day activities to ensure successful study completion. 1.. Study Oversight & Compliance - Lead planning, execution, and management of clinical studies. - Ensure compliance with GCP/ICH guidelines, applicable regulations, and company SOPs. - Act as the primary point of contact for all clinical trial operational activities. 2.. Team Leadership & Coordination - Manage day-to-day activities of the clinical operations team. - Provide guidance and oversight to ensure timelines, budgets, resources, and quality standards are met. 3.. Cross-Functional Collaboration - Work closely with clinical project managers, medical monitors, pharmacokinetics, data management, regulatory affairs, and pharmacovigilance teams. - Ensure efficient and effective study conduct through cross-functional alignment. 4.. Stakeholder Communication - Communicate study progress to internal and external stakeholders. - Identify and mitigate study risks and issues proactively. 5.. Site & Vendor Management - Oversee investigational sites and third-party vendors to ensure high-quality execution. 6.. Documentation & Systems - Ensure clinical project-related documents and systems are developed and maintained to high standards.

Essential Duties and Responsibilities: Your primary responsibility will be to lead and manage all regulatory affairs activities, ensuring the development and execution of robust regulatory strategies throughout the product development and submission process. This role demands strong leadership to effectively guide a team of regulatory professionals, as well as excellent communication skills to engage with regulatory authorities and external stakeholders. 1.. Regulatory Submission Management - Coordinate, prepare, review, and manage regulatory submissions (e.g., INDs, NDAs, variations) to ensure timely approvals. - Prepare and coordinate responses to regulatory agency inquiries and requests for information. 2.. Regulatory Strategy Development - Develop and implement regulatory strategies for new and existing products across all stages of the product lifecycle. - Provide strategic and technical guidance on regulatory requirements for projects at various development stages. 3.. Compliance Oversight - Ensure company products comply with relevant domestic and international regulatory requirements and guidelines. - Evaluate and update company policies and procedures to maintain regulatory compliance. 4.. Cross-Functional Collaboration - Collaborate with cross-functional teams (e.g., R&D, Quality, Manufacturing) to resolve regulatory issues and ensure ongoing compliance. - Advise internal teams on regulatory requirements related to product quality, safety, and efficacy. 5.. Stakeholder Engagement - Represent the company in meetings and negotiations with regulatory agencies and external stakeholders. - Foster relationships with regulatory authorities and industry associations. 6.. Training & Team Leadership - Deliver training and guidance to internal teams on regulatory requirements and changes in the regulatory landscape. - Mentor and support the professional development of junior regulatory staff.