Senior Director, Regulatory Combination Product
Dianthus Therapeutics, Inc.
VP, Regulatory Affairs
Implaion Recruiting
full-time
Posted on:
Location Type: Remote
Location: Remote • North Carolina • 🇺🇸 United States
Visit company websiteJob Level
Lead
About the role
- Take charge of planning, drafting, and submitting global regulatory filings including INDs, NDAs, CTAs, MAAs, and pediatric development plansowning everything from original submissions to post-approval documentation.
- Lead cross-functional teams spanning nonclinical, clinical, CMC, stats, and operations, pushing programs forward while meeting tight timelines and quality expectations.
- Drive strategic and hands-on regulatory operations throughout the product lifecyclefrom first-in-human to commercialization.
- Partner with clinical and safety teams to manage labeling, risk mitigation strategies, pharmacovigilance requirements, and lifecycle management.
- Interface directly with regulatory bodies (FDA, EMA, and others) and confidently lead agency meetings, teleconferences, and written communications.
- Evaluate and implement fast-track mechanisms, adaptive design approaches, and other accelerated regulatory pathways to compress development timelines.
- Ensure internal teams and external partners are aligned and equipped to meet regulatory milestones on time.
- Oversee external regulatory writers and consultants, balancing internal ownership with outsourced support.
- Maintain sharp awareness of global regulatory shiftsincluding FDA, EMA, and evolving EU regulationsand translate that into forward-looking action.
Requirements
- PharmD, PhD, or MD strongly preferred.
- Minimum 10 years in Regulatory Affairs within biopharma, including substantial late-stage and global submission experience.
- Hands-on leadership in at least two successful NDA submissions for novel therapeutics (rare disease background a plus), with meaningful post-approval involvement.
- Proven track record preparing for and navigating regulatory inspectionscalm under pressure, thorough in execution.
- Must have worked in a nimble, small-company setting and be energized by wearing multiple hats in a high-accountability, low-bureaucracy culture.
- Strong command of international regulatory frameworks, including EU Clinical Trial Regulation and CTIS.
- Comfortable leading Advisory Committee strategies and commercial label expansion efforts.
- Fluent in GxP, FDA/ICH guidance, and global PV standards.
- Experience with small molecule programs, ideally in immunology or autoimmune indications.
- Skilled at toggling between high-level strategy and detail-driven executionyou dont shy away from writing submissions yourself.
- Clear communicator, quick thinker, strong collaborator, and decisive leader.
Benefits
- Remote work options
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory filingsINDsNDAsCTAsMAAspediatric development plansregulatory operationspharmacovigilanceNDA submissionsGxP
Soft skills
leadershipcommunicationcollaborationstrategic thinkingdetail-orientedcalm under pressuredecisivequick thinkingadaptabilityexecution
Certifications
PharmDPhDMD
