FSP Regulatory Affairs Manager - Regulatory Intelligence MC
Core
Monitor, analyze, and communicate global regulatory developments to inform client regulatory strategy and operational planning in the biopharmaceutical industry.
Role type
Senior Regulatory Intelligence Manager
Builds
Strategic regulatory intelligence, actionable insights, briefing documents, and project deliverables for pharmaceutical clients
Domain
Biopharmaceuticals / Global Regulatory Affairs
Required skills
Global regulatory frameworks knowledge, Drug development lifecycle expertise, CMC experience, Regulatory intelligence tools proficiency, Generative AI concepts, Project management, Budgeting/forecasting, Analytical writing
Preferred skills
Agentic AI tools experience, Industry forum engagement, Matrix leadership, Negotiation
Technologies
Clarivate, Citeline, Microsoft Office Suite, Generative AI tools, Agentic AI workflows
Responsibilities
Monitor global regulatory changes and policy trends across key markets; Synthesize information to assess implications for client development programs; Conduct regulatory precedent searches; Maintain centralized regulatory intelligence repository; Provide senior review and advice for regional regulatory submissions; Manage project budgeting and forecasting; Collaborate on business development and proposal texts; Lead and train junior team members.
Seniority
Senior, hands-on IC with strategic oversight