Director, Regulatory Affairs

Summary

Join Dianthus Therapeutics, a clinical-stage biotechnology company, as their Director of Regulatory Affairs. You will develop and execute global regulatory strategies, serving as the global regulatory lead for the MMN program. Collaborate with cross-functional teams, manage global regulatory submissions, and liaise with Health Authorities. This role requires expertise in US and international regulations and involves guiding the development of regulatory documents from early phases through marketing approval. The position offers remote work flexibility and the opportunity to contribute to a growing organization focused on developing transformative medicines. You will be responsible for strategic regulatory assessments, interactions with Health Authorities, and leading the preparation of regulatory submissions.

Requirements

• Bachelor's degree and a minimum of 8 years of experience in Regulatory Affairs
• Demonstrated track record of successful interactions with FDA and other Health Authorities
• Expert understanding of scientific principles and regulatory requirements relevant to global drug development
• Preparation of nonclinical and clinical sections of regulatory filings, including IND/CTAs, PIPs, briefing documents, and BLA/MAAs
• Preparation for and conduct of Regulatory meetings with global Health Authorities for complex issues
• Strong interpersonal skills and the ability to collaborate effectively with subject matter 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

• Represent regulatory on cross-functional teams; provide leadership and strategic direction for regulatory deliverables
• Lead planning and provide hands-on support for development and on-time delivery of clear and persuasive global regulatory submission documents, including INDs/CTAs, DSURs, pediatric investigation plans (PIPs), responses to Health Authority (HA) queries, and briefing documents
• Identify, communicate, and propose resolutions to routine and complex strategic issues
• Serve as primary contact and build trusted relationships with Health Authorities for assigned program(s)
• Maintain expert knowledge in US and international regulations and provide proactive regulatory intelligence
• Assess opportunities and oversee applications for expedited pathways (eg, fast track or breakthrough designation or PRIME) and/or orphan drug designations
• Lead preparation for and conduct of Health Authority meetings
• Guide development of core data sheet
• Evaluate competitive landscape, regulatory approval pathway(s), and labeling precedent(s)
• Identify, engage and collaborate with external regulatory experts and consultants
• Perform regulatory strategic assessments for new product candidates and new indications
• Support departmental initiatives, including process and infrastructure development, regulatory intelligence, budgeting, and authoring of departmental documents (eg, SOPs and Regulatory Development Plans)

Preferred Qualifications

Rare disease, neurology, CMC, and/or combination product experience

Benefits

We are open to you working remotely