Senior/Executive Director, Regulatory Affairs
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Job Description
Senior Director/Executive Director of Regulatory Affairs developing global strategies for drug approval at Dianthus Therapeutics. Leading regulatory submissions and cross-functional collaboration with health authorities in autoimmune disease treatments.
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).
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
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