Dianthus Therapeutics, Inc. · 3 months ago
Senior Director, Regulatory Affairs
United States
Full-time
Remote
Director/Executive
10+ years expDianthus Therapeutics is developing potentially best in class therapies for patients living with severe autoimmune diseases. The Senior Director of Regulatory Affairs will develop and execute global regulatory strategies, serving as the global regulatory lead for the multifocal motor neuropathy program while ensuring compliance with Health Authority regulations.
BiopharmaBiotechnologyHealth Care
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
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)
Qualification
Required
Bachelor's degree and a minimum of 10 years of direct experience in Regulatory Affairs; rare disease, neurology, CMC, advanced degree (MS, PharmD, PhD), and/or combination product experience a plus
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
Company
Dianthus Therapeutics, Inc.
Dianthus Therapeutics, Inc.
11-50 employees
Funding
Current Stage
Public CompanyTotal Funding
$639.5M2025-09-09Post Ipo Equity· $288M
2024-01-22Post Ipo Equity· $230M
2023-09-12IPO
Leadership Team
Marino Garcia
President & Chief Executive Officer, Board Member
Ryan Savitz
Chief Financial Officer
Recent News
Clinical Trials Arena
2025-12-25
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