Associate Director, GRA
Core
Global Regulatory Lead driving regulatory strategies for clinical and commercial therapeutic programs in muscle, CNS, and cardiac diseases.
Role type
Senior IC Global Regulatory Lead (Associate Director)
Builds
Regulatory submissions, briefing packages, and strategies for global health authority interactions
Domain
Biopharmaceuticals / Gene Therapy / Regulatory Affairs
Required skills
Drug development process knowledge, regulatory submission preparation, global health authority engagement, budget and schedule management, cross-functional leadership, regulatory compliance
Preferred skills
Experience in major markets, ability to lead without authority, adaptability to change
Technologies
INDs, CTAs, NDAs, regulatory reporting tools
Responsibilities
Develop regulatory strategies incorporating totality of development, represent company at FDA and global health authority meetings, lead regulatory teams in multi-disciplinary strategy, coordinate submissions for assigned products, ensure document quality and scientific accuracy, guide study teams on regulatory implementation
Seniority
Senior, hands-on IC with strategic oversight