Dianthus Therapeutics, Inc. · 2 months ago
Manager, Regulatory Clinical Applications
Waltham, MA
Full-time
Hybrid
Senior Level
5+ years expDianthus Therapeutics, Inc. is developing innovative therapies for severe autoimmune diseases. The Manager of Regulatory Clinical Applications will support the planning and execution of clinical trial application activities, ensuring compliance and timely startup of global studies.
BiopharmaBiotechnologyHealth Care
Responsibilities
Support the Director in coordinating and implementing study startup activities in collaboration with CROs and internal study teams
Assist in identifying country-specific regulatory and ethics committee requirements to facilitate timely CTA approvals
Review and prepare submission packages for Regulatory Authorities and IRB/IEC for completeness and accuracy
Ensure required Quality documentation (e.g., QP declaration, GMP Certification) is available for drug release
Track and coordinate responses to Regulatory and IRB/IEC queries and deficiency letters with subject matter experts
Monitor and report on CTA status updates and study startup progress across assigned projects
Maintain internal regulatory files and ensure documentation is complete and accessible
Support the review and maintenance of the Trial Master File for regulatory and ethics committee documentation
Update global clinical trial registries (e.g., ClinicalTrials.gov) as required
Participate in Study Management Team meetings to represent regulatory/study startup perspectives
Assist in gathering and sharing regulatory intelligence related to study startup
Contribute to the development and maintenance of SOPs and process improvement initiatives
Support strategic planning and risk mitigation efforts related to study startup activities
Travel up to 10% for team meetings and company events
Qualification
Required
Bachelor's degree in life sciences or related field required
5+ years of experience in clinical trial startup and regulatory affairs within the pharmaceutical or biotech industry
Familiarity with CRO operations and global regulatory requirements for clinical trial applications
Experience supporting global interventional clinical studies and managing CTA submissions
Strong organizational skills with the ability to manage multiple priorities and meet deadlines
Knowledge of GxP, ICH guidelines, and health authority regulations
Effective communication and interpersonal skills; ability to work collaboratively across teams
Detail-oriented with strong analytical and problem-solving capabilities
Proficiency in project management and documentation systems
Preferred
advanced degree preferred
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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