About Us

About the Role

The Senior Director/Executive Director of Regulatory Affairs will develop and execute global regulatory strategies in collaboration with key stakeholders.

You will serve as the global regulatory lead for our new asset (DNTH212) in multiple programs, providing expert guidance to cross-functional teams, driving global regulatory submissions, acting as primary liaison with Health Authorities, and interpreting applicable Health Authority regulations and guidance documents to ensure compliance.

This is a unique opportunity to join a growing organization with an expanding pipeline, and to play an integral role in the in the global development of assigned programs from early phase through marketing approval. We are building a culture of individuals who hold our core principles at the center of our operations, with the goal to elevate the care of our patients’ lives. We are open to you working remotely within the contiguous United States or Canada.

Key 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).

Experience

• 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.