Director, Regulatory* job opportunity at Precision Medicine Group.

Bachelor's (B.Sc.)

Taiwan

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Provide strategic, technical, and regulatory guidance to #clients and team members in the area of clinical development of human #medicinal products and drug development life cycle Establish operational objectives and assignments for assigned team members Track and report regulatory function metrics and key performance indicators Oversee, review and provide strategic input on applications to Regulatory Authorities including, but not limited to, #CTA/IND, annual reports, routine amendments, scientific advice/regulatory authority meetings, orphan designations, paediatric planning, and expedited pathways As needed, review documents intended for submission to the Regulatory Authorities and/or Ethics Committees to ensure compliance with regulatory standards Select, train, develop, coach and manage the performance of Regulatory Managers, ensuring the sharing of best practices across the team Oversee resource allocation and #utilization of Regulatory Managers. As needed, represent Global Regulatory Affairs at project team meetings with both external and internal customers and manage/oversee regulatory workflow between departments Provide oversight to filing and study teams regarding regulations/guidelines and company #SOPs to ensure successful and high-quality regulatory applications Ensure budgets and plans meet corporate requirements Provide ICH/GCP/Regulation guidance, advice and training to internal and external clients Participate in developing, implementing, and maintaining the corporate quality initiatives across business units within Clinical Solutions/Precision for Medicine Implement regulatory tools to support the department Assist in developing, modifying and executing company policies that affect Regulatory Affairs and may impact other departments Support #QA audits and/or assign applicable team members to participate in audits Establishes and maintains a high level of technical knowledge in the area of product development and international regulatory affairs. Interprets emerging regulatory requirements and collaborates in impact assessment and implementation Supports #Business Development in generation of customer focused, well-presented regulatory proposal content and budgets, partnering with other functional areas as required to define bid content, strategy, scope of work