Senior Director, Regulatory Clinical Strategy
Core
Directs and implements global regulatory projects and clinical strategy for non-opioid pain management and regenerative health solutions.
Role type
Senior Director, Regulatory Clinical Strategy
Builds
Regulatory submission documents, global regulatory strategy, and health authority communications for drug development programs.
Domain
Pharmaceutical industry, regulatory affairs, clinical strategy
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Strategic thinking, regulatory pathway analysis, cross-functional team leadership, project management, data analysis, negotiation, problem-solving, policy intelligence
Preferred skills
Managerial experience, global regulatory knowledge, vendor management, budgeting
Technologies
MS Word
Responsibilities
Lead development of regulatory strategy for complex projects from first-in-human to post-marketing; advise senior management on global regulatory tactics; align cross-functional teams on project plans and timelines; supervise and mentor direct reports; manage vendors and contractors; drive process improvements and support budgeting.
Seniority
Senior Director, strategic leadership with direct supervisory responsibilities