Client dedicated Global Regulatory Lead - Early Development
Core
Client-embedded regulatory leader driving global strategies for early clinical development from first-in-human planning through initial studies.
Role type
Senior IC Global Regulatory Lead (Early Development)
Builds
Global regulatory strategies and submissions for early-stage biopharmaceutical programs
Domain
Biopharmaceuticals / Early Clinical Development
Required skills
Global regulatory strategy, First-in-human planning, IND/CTA submissions, FDA/EMA interaction, Vendor oversight, Regulatory change management, Cross-functional coordination, Strategic planning, Project management, Stakeholder influence
Preferred skills
PhD or PharmD, Orphan drug development experience, Deep preclinical knowledge (optional), Matrix team execution
Technologies
Regulatory submission systems, Health authority portals
Responsibilities
Develop global regulatory strategies for early clinical programs, Advise teams on regulatory requirements and nonclinical package support, Represent regulatory function in governance forums, Coordinate regulatory documents and submissions (INDs, CTAs), Support interactions with health authorities (FDA, EMA), Monitor global regulatory changes, Oversee regulatory vendors, Mentor colleagues
Seniority
Senior, hands-on IC