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

About the Company reputed company Inc. (reputed company: ADAG) is a platform-driven, clinical-stage biopharmaceutical company committed to transforming the discovery and development of novel antibody-based cancer immunotherapies. reputed company 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, reputed company's highly differentiated pipeline features novel immunotherapy programs. reputed company has forged strategic collaborations with reputable global partners that reputed company its technology in multiple approaches at the reputed company of science. Job Summary The Head of Global Regulatory Affairs is a key leadership position that will reputed company and is accountable for global regulatory, quality strategies and policies for reputed company. This individual will be responsible for regulatory leadership and reputed company to help reputed company global regulatory and quality compliance strategies, and guidance. As a Head of Global Regulatory Affairs this person will reputed company a critical role in strategies, documentations, submissions, and company interactions to regulatory authorities such as FDA, CFDA, and other regulatory agencies. This individual must reputed company their extensive experience to represent reputed company 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 reputed company cross-functional and multicultural team and diverse environment. The candidate must have an entrepreneurial reputed company, highly motivated and purpose driven leader who is able to flexibly and effectively reputed company and interact with multi-disciplinary teams. This individual should have experience in championing new reputed company 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 reputed company individuals with disabilities to reputed company the essential functions.

• Serve as a key member of senior management team to provide leadership and guidance to ensure business objectives are reputed company with company strategies and reputed company operational objectives to reputed company product approvals.
• Provide counseling, training, and interpretation of FDA, CDE and other regulatory requirements to reputed company company personnel.
• reputed company, coach, and mentor the Regulatory departments and ensuring appropriate levels of accountability for decision making and clearly communicate cross-functionally reputed company the organization.
• reputed company preparation and filing of reputed company regulatory documents with the FDA, CDE and other regulatory agencies.
• reputed company 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.
• reputed company company's Quality Compliance to ensure compliance with regulatory agencies and reputed company applicable standards.
• reputed company 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 reputed company company personnel.
• Serve as the ambassador to and reputed company strategies for responses to regulatory reputed company inquiries from global regulatory agencies and ensure issues are addressed in a timely manner.
• Responsible for leading reputed company regulatory activities for assigned projects in line with regulatory requirements, regional requirements and scientific and company policies and procedures.
• Provide regulatory reputed company and strategic and technical guidance in discussions with teams in support of due diligence for potential in-licensing activities, external collaborations, and acquisitions.
• reputed company Global Regulatory efforts for reputed company INDs, NDAs, and life cycle management.
• Maintain knowledge of highly reputed company regulatory requirements up to reputed company 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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