Dianthus Therapeutics, Inc.

Senior/Executive Director, Regulatory Affairs

Dianthus Therapeutics, Inc.

full-time

Posted on:

Location Type: Remote

Location: Canada

Visit company website

Explore more

✨ AI Apply
Apply

Job Level

Senior

About the role

  • 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).

Requirements

  • Bachelor's degree and a minimum of 12 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
  • N/A 📊 Check your resume score for this job Improve your chances of getting an interview by checking your resume score before you apply. Check Resume Score
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
regulatory submissionsINDsCTAsDSURspediatric investigation plansBLAMAAsregulatory filingsregulatory strategic assessmentsexpedited pathways
Soft Skills
leadershipproblem-solvingflexibilityteamworkinterpersonal skillscollaborationcommunicationwritingpresentation skillsproject management
Certifications
Bachelor's degreeMSPharmDPhD