Head of Global Regulatory Affairs (U.S. Remote)

About the Company

Adagene Inc. (Nasdaq: ADAG) is a platform-driven, clinical-stage biopharmaceutical company committed to transforming the discovery and development of novel antibody-based cancer immunotherapies. Adagene combines computational biology and artificial intelligence to design novel antibodies that address unmet patient needs. Powered by its proprietary DPL platform, composed of NEObody, SAFEbody, and POWERbody technologies, Adagene's highly differentiated pipeline features novel immunotherapy programs. Adagene has forged strategic collaborations with reputable global partners that leverage its technology in multiple approaches at the vanguard of science. Job Summary The Head of Global Regulatory Affairs is a key leadership position that will oversee and is accountable for global regulatory, quality strategies and policies for Adagene. This individual will be responsible for regulatory leadership and oversight to help develop global regulatory and quality compliance strategies, and guidance. As a Head of Global Regulatory Affairs this person will perform a critical role in strategies, documentations, submissions, and company interactions to regulatory authorities such as FDA, CFDA, and other regulatory agencies. This individual must leverage their extensive experience to represent Adagene in regulatory affairs in discussions with internal and external stakeholders. This role will provide global regulatory expertise and contribute to the delivery of the Clinical, R&D and Operations strategies. This individual will lead cross-functional and multicultural team and diverse environment. The candidate must have an entrepreneurial mindset, highly motivated and purpose driven leader who is able to flexibly and effectively lead and interact with multi-disciplinary teams. This individual should have experience in championing new ideas in a dynamic, international, and innovative environment. The successful candidate will have a track record of accomplishments in global regulatory affairs, project management, strong collaboration, and communication skills. This position may require travelling to our company headquarters in Suzhou, China. Essential Functions Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Serve as a key member of senior management team to provide leadership and guidance to ensure business objectives are aligned with company strategies and achieve operational objectives to gain product approvals.
• Provide counseling, training, and interpretation of FDA, CDE and other regulatory requirements to all company personnel.
• Lead, coach, and mentor the Regulatory departments and ensuring appropriate levels of accountability for decision making and clearly communicate cross-functionally within the organization.
• Oversee preparation and filing of all regulatory documents with the FDA, CDE and other regulatory agencies.
• Develop and maintain external relationships with key opinion leaders and regulatory officials.
• Direct the development of systems, practices, and processes to ensure effective ongoing review of clinical development plan, product design and/or manufacturing changes and adverse events.
• Provide leadership and direction for significant deviation events that may impact compliance status or represent the significant business risk.
• Responsible for company's product quality and reliability to meet or exceed regulatory.
• Lead company's Quality Compliance to ensure compliance with regulatory agencies and all applicable standards.
• Develop and execute quality design and quality assurance strategy for new product development and sustaining business activities.
• Support the quality system, provide effective leadership support, training, and guidance to all company personnel.
• Serve as the ambassador to and develop strategies for responses to regulatory related inquiries from global regulatory agencies and ensure issues are addressed in a timely manner.
• Responsible for leading all regulatory activities for assigned projects in line with regulatory requirements, regional requirements and scientific and company policies and procedures.
• Provide regulatory oversight and strategic and technical guidance in discussions with teams in support of due diligence for potential in-licensing activities, external collaborations, and acquisitions.
• Lead Global Regulatory efforts for all INDs, NDAs, and life cycle management.
• Maintain knowledge of highly complex regulatory requirements up to current date, while influencing preparation of new regulatory guidance wherever possible.
• Champion initiatives that contribute to global process improvements, which have a significant impact on business.
• Direct activities of Contract Manufacturing Organizations (CMOs) and Contract Research Organization's (CRO's), material suppliers, consultants, and vendors.
• Other projects or responsibilities as may be required.

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