Senior Director, Regulatory Affairs

Senior Director, Regulatory Affairs

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.

The Senior Director of Regulatory Affairs will develop and execute global regulatory strategies in collaboration with key stakeholders.

You will serve as the global regulatory lead for our multifocal motor neuropathy (MMN) program and support other programs as needed, providing expert guidance to cross-functional teams, driving global regulatory submissions, acting as primary liaison with Health Authorities, and interpreting applicable Health Authority regulations and guidance documents to ensure compliance.

This is a unique opportunity to join a growing organization with an expanding pipeline, and to play an integral role in the global development of assigned programs from early phase through marketing approval. 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 within the United States.

Key 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).

Experience :