• Build and develop XDC RA CMC organization that provides strategic leadership and operational excellence in cross-functional teams to assure the highest RA CMC standards across all development and late-stage programs to ensure successful regulatory filings.
• Provide regulatory CMC guidance to RA Functional Leads to ensure development activities are compliant with relevant guidelines and governmental regulations.
• As RA Functional Sponsor, lead and support the preparation of CMC regulatory submissions including scientific and technical review for accuracy, soundness, and regulatory appropriateness.
• Provide strategic advice and direction to junior staff within the department for assigned projects. Oversees planning and execution of global regulatory activities and submissions. Ensure the development of robust global regulatory strategies for the projects.
• Lead and drive global CMC submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects.
• Review and/or author high-quality CMC documentation for IND/BLA/MAA submissions, establishing and applying CMC global regulatory strategies, current regulatory trends, and guidelines. Ensure technical congruency and regulatory compliance, meeting agreed upon timelines.
• Develop and maintain professional partnerships with both internal and external stakeholders.
• Formulate, lead, and drive global CMC regulatory strategy for assigned projects drawing on substantial regulatory expertise with a focus on innovation, maximizing the business benefit balanced with regulatory risks and compliance.
• Identify and implement phase-appropriate regulatory strategies to support the product lifecycle from IND to BLA and beyond.
• Lead and drive global CMC submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects.
• Review and/or author high-quality CMC documentation for IND/BLA/MAA submissions, establishing and applying CMC global regulatory strategies, current regulatory trends, and guidelines. Ensure technical congruency and regulatory compliance, meeting agreed upon timelines.
• Initiate and lead project team activities related to Health Authority interactions and negotiations: setting objectives, preparing briefing books, coordinating, and planning rehearsals and risk mitigation plans.
• Provide regulatory assessments of new business opportunities as required.
• Foster strong relationships with FDA, EMA, NMPA and international regulatory authorities.