Regulatory analyst

• Regulatory Feasibility: Evaluate potential FDF projects, initial market entry requirements, and variation pathways.
• Strategic Input: Work closely with the Market Intelligence and Project Management teams to provide early-stage regulatory risk assessments.
• Gap Analyses: Assist in gap analyses and prepare high-quality responses to regulatory authority questions.
• Stakeholder Coordination: Coordinate document collection, clarification, and submission tracking with internal stakeholders and CDMOs.
• Project Scoping: Assess country-specific requirements for target markets, identifying potential hurdles and timelines.