百瑞精鼎國際股份有限公司

百瑞精鼎提供多元職場環境，歡迎身心障礙夥伴的加入。 為提供及增加身心障礙夥伴的就業機會，開立此投遞專區，歡迎相關人才踴躍投遞。 1. 歡迎持身心障礙手冊人才主動投遞，有意應徵者請以104系統投遞履歷，並請於個人履歷註明「欲應徵的職務」，如有合適職缺，本公司將主動聯繫通知，不合適者則不另通知。 2. 本公司目前開放之職缺內容，請參考104職缺說明，如有符合專長、經歷或興趣等工作機會，請主動投遞履歷，以增加面試機會。

Job Description Summary We are seeking an experienced and strategic-minded Director of Regulatory CMC Strategy to join our senior leadership team. This pivotal role involves providing high-level strategic direction for late-stage and marketed products, as well as critical cross-project initiatives. The ideal candidate will have extensive experience in developing and implementing CMC strategies, managing complex regulatory submissions, and leading interactions with health authorities. Strategic Leadership: Provide strategic direction and oversight for CMC aspects of late-stage and marketed products Deliver strategic input on critical cross-project topics, ensuring alignment with overall business objectives Develop comprehensive CMC strategies to support product development, registration, and lifecycle management Regulatory Strategy and Submissions: Develop and oversee CMC strategies for complex regulatory submissions, including: Investigational New Drug (IND) applications Investigational Medicinal Product Dossiers (IMPDs) Biologics License Applications (BLAs) Marketing Authorization Applications (MAAs) Post-approval variations/supplements Responses to health authority questions Author and review high-level regulatory submissions Ensure all submissions conform to relevant health authority guidelines and regulations Lead submission preparation meetings and coordinate cross-functional input Health Authority Interactions: Lead regulatory CMC discussions and interactions with Health Authorities Represent the company in high-level meetings with regulatory agencies Develop strategies for addressing complex regulatory questions and issues Build and maintain positive relationships with key regulatory stakeholders Regulatory Assessment and Change Management: Oversee regulatory assessments of manufacturing changes Establish data requirements and strategies for regulatory submissions related to manufacturing changes Provide expert guidance on CMC-related regulatory implications of proposed changes Project Management and Leadership: Represent Regulatory CMC at high-level project team meetings and governance committees Lead critical submission preparation meetings and regulatory strategy discussions Address complex reviewer comments and manage sensitive regulatory correspondence Provide regular updates to senior management on project status, risks, and key milestones Mentor and develop team members in Regulatory CMC practices and strategic thinking Cross-functional Collaboration: Work closely with senior leaders across various departments, including R&D, Manufacturing, Quality Assurance, and Clinical Development Facilitate effective communication between internal teams, external partners, and regulatory authorities Provide expert CMC regulatory guidance to support critical business decisions and product lifecycle management Regulatory Intelligence and Innovation: Stay at the forefront of evolving CMC regulations, guidelines, and industry best practices Drive the development and implementation of innovative CMC regulatory strategies Participate in and potentially lead relevant industry groups and regulatory authority initiatives Desired Qualities: Visionary leader with the ability to anticipate and navigate complex regulatory challenges Strategic thinker with a talent for innovative problem-solving and risk management Strong leadership skills with the ability to influence cross-functional teams and senior management Proactive and self-motivated with a commitment to regulatory excellence Adaptable to changing priorities and evolving regulatory landscapes Excellent interpersonal skills with the ability to build strong relationships with internal and external stakeholders Detail-oriented with a focus on quality and accuracy, while maintaining a big-picture perspective Ability to thrive in a fast-paced environment and manage competing priorities

Key Accountabilities: • Initiates and coordinates activities and essential documents management during start-up towards the compilation of a high-quality Investigator Initiation Package (IIP) leading to approval for site initiation • Registers investigator sites and Client stakeholders in Client registries and systems as required. Updates and regularly maintains the registry with accuracy and inspection readiness • Works directly and interacts with investigator sites to confirm readiness for site start-up by reviewing study site profile ready in Shared Investigator Platform (SIP) or reviewing/completing critical information Sheet, inclusive of but not limited to Investigator Initiation Packages (IIP) essential documents components, site contracts contacts, clinical supply shipment information, payment information, IRB submission and status • Takes the lead to resolve issues or concerns and escalates site issues timely, where applicable • Prepares, validates and submits regulatory documents such as completed IIP, IRB approval forms, and FDA 1572/Attestation Form for internal regulatory approval within required timelines • Manages and coordinates with other supporting roles to ensure timely site activation and operational activities • Supports the compilation of the Central Investigator Review Board (IRB) package and submissions to approval of the study (where applicable) and other committees as per country requirements • Coordinates the timely communication, documentation and responses between Client and Central Ethics committee to bring clinical study to approval (country dependent) • Supports investigator’s sites with local IRB workflow from preparation, submission through approval • Assists with preparation, handling and distribution of non-Clinical Trial Supplies and maintenance of tracking information as needed • Collaborates with the Study Team on the development and readiness of sites electronic Investigator Site File (eISF) when utilized, acts as primary point of contact for the sites, and manages the Site Operations/CRO monitor access to eISF prior to Site Initiation Visit (SIV) • Assists with the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures • Supports and implements activities in SIP to align with Client strategy as it relates to the role • Coordinates translation of documents that are within scope with the preferred translation vendors • May serve as SAP Point of Contact (PoC) on a study conducted in multiple countries • May serve as a Subject Matter Expert (SME) on a project, initiative, system and/or process, and represent the SAP function as applicable • Supports the mentoring of new hires on processes and systems Clinical Trials Conduct : • Post site activation, initiates and coordinates activities and essential documents management with the investigator’s sites towards the compilation of high-quality documents and updates through the life cycle of a study, such as the documents management for protocol amendments, FDA 1572/Attestation revisions, Ethics Committee annual approvals, and other activities required during study conduct • Ensures maintenance of IRB/Ethics and other committees’ activities as applicable • Files documents timely to the Trial Master File and assists with periodic quality review of study files for accuracy and completeness • Accurately updates and maintains clinical trial systems that track site compliance and performance within project timelines • Supports investigator sites and study teams to prepare for and provide responses to site audits/inspections