Executive Director, Regulatory Affairs
Core
Visionary leader shaping long-term regulatory strategy for clinical-stage biotechnology programs, ensuring compliance and driving organizational impact.
Role type
Executive Director, Regulatory Affairs (Strategy & Leadership)
Builds
Global regulatory strategies, corporate policies, and regulatory pathways for neuromuscular disease therapeutics.
Domain
Biotechnology / Clinical-stage drug development / Neuromuscular diseases
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulatory strategy, FDA/EMA compliance, CTD format expertise, rare disease designations (Orphan/Fast Track), team leadership, stakeholder negotiation, regulatory writing, cross-functional collaboration
Preferred skills
Master's degree in life sciences, deep industry knowledge, innovation in regulatory science
Technologies
CTD format, IND/CTA/NDA/BLA/MAA filings
Responsibilities
Shape global regulatory strategy for programs, lead interactions with health authorities (FDA, EMA), oversee major regulatory filings, direct expedited program designations, mentor senior regulatory professionals, lead inspections and audits, contribute to corporate strategy.
Seniority
Executive, strategic leadership & mentorship
