Dianthus Therapeutics - Associate Director, Regulatory CMC
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Requirements
• Bachelor's degree and a minimum of 8 years of experience in Regulatory CMC for biotherapeutics, biologics experience required; drug/device combination product experience a plus. • Demonstrated track record of successful interactions with FDA and other Health Authorities related to CMC submissions. • Expert understanding of scientific principles and regulatory CMC requirements relevant to global drug development. • Preparation of Quality sections of regulatory dossiers, including IND/CTA/IMPDs, briefing documents, and BLA/MAAs. • Preparation for and conduct of Regulatory CMC meetings with global Health Authorities for complex issues. • Strong interpersonal skills and the ability to collaborate effectively with technical area experts. • Demonstrated leadership, problem-solving ability, flexibility, and teamwork. • Excellent communication, writing, and presentation skills, with the ability to effectively convey critical information to project teams, senior management, and external stakeholders. • Strong project management skills. • Ability to work effectively in a fast-paced, collaborative, and dynamic environment.
Responsibilities
• Provide leadership and strategic direction for regulatory CMC deliverables, including drug/device combination products. • Identify, communicate, and propose resolutions to routine and complex strategic issues. • Lead planning and provide hands on support for development, and on-time delivery of clear and effective global CMC regulatory submission documents. • Act as primary contact with Health Authorities for CMC-related matters; lead preparation for and conduct of agency meetings. • Maintain expert knowledge in US and international biopharmaceutical and combination product regulations and provide proactive regulatory intelligence. • Review and provide regulatory assessments on change controls. • Identify regulatory opportunities and risks and communicate them to project teams and senior management in a clear and concise manner. • Provide regulatory advice and make reasoned decisions on regulatory issues for which there may not be clear/specific regulatory guidance. • Identify, engage and collaborate with external regulatory experts and consultants. • Support departmental initiatives, including process and infrastructure development, budgeting, and authoring of departmental documents, such as SOPs and Regulatory Development Plans.
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