Senior Director, Regulatory Affairs
Core
Leads a team of regulatory professionals to review U.S. promotional materials for pharmaceutical products, ensuring alignment with FDA regulations and corporate strategy.
Role type
Senior Director, Regulatory Affairs (Management)
Builds
Regulatory strategy and compliant promotional materials for pipeline and in-line products
Domain
Pharmaceutical/Biologics Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Team Leadership, FDA Regulatory Strategy, Cross-Functional Project Management, Clinical Development Knowledge, Policy Development, Stakeholder Negotiation, Risk Assessment, Strategic Planning, Regulatory Compliance, Process Redesign
Preferred skills
Science-related degree background, Experience with OPDP/APLB, External Regulatory Committee Participation
Technologies
None explicitly stated
Responsibilities
Lead regulatory review of promotional materials, Partner with commercial/legal/medical teams, Drive regulatory strategy for therapeutic franchises, Manage escalations with senior leadership, Present at external regulatory meetings, Develop and implement strategic initiatives
Seniority
Senior Director, Management