Senior Manager, Global Regulatory Strategy
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Job Description
Senior Manager shaping global regulatory strategy for Telix’s precision-medicine radiopharmaceutical portfolio. Leading early-stage submissions and health-authority interactions across global markets.
Responsibilities:
- Oversee regulatory activities for assigned early-stage portfolio across global markets
- Execute global regulatory strategy for assigned assets
- Plan and deliver submissions from IND/CTA through early registration
- Provide regulatory expertise for early-stage programs
- Prepare health authority interactions
- Support the VP, Global Regulatory Strategy, on global regulatory planning and cross-functional initiatives
- Develop submission plans, timelines, and content requirements
- Support registration strategies and manage registration processes
- Prepare briefing packages and supporting materials for health authority meetings
- Draft meeting minutes and responses to agency questions
- Interface with FDA, EMA, TGA, PMDA, and other health authorities
- Partner with QA, Clinical Development, Research & Innovation, and other functions to assemble compliant, on-time dossiers
- Provide regulatory guidance to project teams
- Identify regulatory risks and recommend mitigation plans
- Monitor evolving global health authority regulations and guidelines
- Manage responses to health authority queries, variations, and post-approval requirements
Requirements:
- Bachelor’s degree in Life Sciences, Pharmacy, Regulatory Affairs, or a related field (advanced degree preferred)
- 8+ years of experience in Regulatory Affairs, with strong early-stage (IND/CTA) submission experience
- Strong experience in clinical regulatory submissions (CTAs, INDs) and early-stage development
- Working knowledge of global regulatory frameworks (FDA, EMA, TGA, PMDA, Health Canada, Medsafe)
- Experience preparing for and supporting health authority interactions
- Strong knowledge of ICH guidelines and CTD/eCTD submissions
- Knowledge of the regulatory lifecycle
- Strong communication, collaboration, adaptability, ethical behavior, and continuous learning capabilities
Benefits:
- Annual performance-based bonuses
- Equity-based incentive program
- Generous vacation
- Paid wellness days
- Support for learning and development
- Competitive salaries
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