Senior Director, Regulatory Affairs

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October 20

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Dianthus Therapeutics, Inc.

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Biotechnology • Pharmaceuticals

Dianthus Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing novel monoclonal antibodies to treat severe autoimmune and inflammatory diseases. The company leverages advanced antibody engineering technologies to create next-generation complement therapeutics with improved selectivity and potency. Its lead program, DNTH103, is a monoclonal antibody targeting the classical complement pathway for conditions such as generalized Myasthenia Gravis, Multifocal Motor Neuropathy, and Chronic Inflammatory Demyelinating Polyneuropathy. Based in New York City and Waltham, Massachusetts, Dianthus aims to deliver transformative medicinal therapies by addressing unmet needs in autoimmune treatment.

2 - 10 employees

Founded 2017

🧬 Biotechnology

💊 Pharmaceuticals

💰 $100M Private Equity Round on 2022-04

📋 Description

• 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 (e.g., 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 (e.g., SOPs and Regulatory Development Plans).

🎯 Requirements

• 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.

🏖️ Benefits

• Health Insurance • Flexible Work Arrangements