Manager, Regulatory Affairs

Summary

Join Dianthus Therapeutics, a clinical-stage biotechnology company, as their Manager, Regulatory Affairs. You will support global development programs, collaborating with key stakeholders and reporting to the SVP, Regulatory Affairs. This role focuses on clinical trial applications (CTAs), regulatory planning, and facilitating global submissions. You will play an integral role in creating and implementing regulatory strategies from early development through marketing approval. The position offers remote work flexibility and the opportunity to contribute to a growing organization with an expanding pipeline. Dianthus is building a culture centered around core principles and elevating patient care.

Requirements

• Bachelor's degree required
• Experience within the biotech or pharmaceutical industry required
• Understanding of regulatory requirements for drug development and approval
• Demonstrated problem-solving ability, flexibility, and teamwork
• Experience in preparing and submitting CTAs, INDs, and other regulatory documents
• Excellent written and verbal communication skills with attention to detail
• Strong organizational and project management skills
• Good interpersonal skills and the ability to work collaboratively across departments and with external partners

Responsibilities

• Ensure appropriate planning, tracking, and alignment of contents and timelines for regulatory submissions, including Investigational New Drug (IND) applications, clinical trial applications, IND/CTA amendments, notifications, and reports
• Represent regulatory at study management team meetings
• Liaise with CRO to ensure that a comprehensive list of country requirements and potential challenges is generated and communicated to team
• Facilitate health authority query management and submission of responses, including scheduling of cross-functional team meetings
• Contribute to preparation of submission components in conformance with regulatory requirements and strategies to ensure high quality and timely submissions
• Maintain accurate records of communications with health authorities and track application status
• QC regulatory components of Trial Master Files for accuracy and completeness
• Create and manage health authority query and commitment trackers
• Assist global regulatory leads with execution of regulatory strategies
• Build and apply knowledge of FDA, EU Clinical Trial Regulation, and other international regulatory requirements for clinical trials to determine potential risks, impacts, and mitigations
• Support departmental initiatives, including process and infrastructure development

Preferred Qualifications

Rare disease and/or neurology product experience

Benefits

We are open to you working remotely