Manager, Regulatory Clinical Applications

Manager, Regulatory Clinical Applications

We are developing potentially best in class therapies for patients living with severe autoimmune diseases. Our lead antibody, claseprubart (DNTH103), is purposefully engineered with extended half-life, improved potency, and high selectivity for only the active C1s complement protein that drives disease pathology enabling less frequent and more convenient self-administered subcutaneous injections. Our second clinical candidate, DNTH212 is a first and potentially best in class, bifunctional inhibitor that targets clinically validated and complementary disease modifying mechanisms, Type 1 IFN suppression and B cell modulation enabling potential for improved clinical outcomes and patient friendly convenient, self-administered subcutaneous injections.

As the Manager, Regulatory Clinical Applications, you will play a key role in supporting the planning and execution of clinical trial application (CTA) activities across global studies.

Reporting to the Director of Regulatory Clinical Applications Strategy, you will collaborate closely with Clinical Research Organizations (CROs), internal stakeholders, and regulatory bodies to ensure timely and compliant study startup and maintenance. You must have experience with clinical trial applications to be successful in this role.

This is an exciting opportunity to contribute to a growing regulatory function within a clinical-stage company, supporting strategic initiatives and operational excellence throughout the study lifecycle. We are building a culture of individuals who hold our core principles at the center of our operations, with the goal to elevate the care of our patients' lives. We are open to you working remotely in the United States.

Key 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.

Experience