Compliance Manager overseeing complex account opening, KYC and AML compliance for Fidelity Clearing Canada. Supporting regulatory monitoring, training, reporting and risk workflows.
TL
Associate Director, Global Regulatory Strategy
Posted 11 hours ago
About the role
- Associate Director leading global regulatory strategy for Telix’s radiopharmaceutical PSMA portfolio. Supporting worldwide submissions, approvals, lifecycle management, and health-authority interactions.
Responsibilities
- Lead regulatory activities for clinical and commercial registrations across global markets
- Manage overall regulatory oversight of the PSMA franchise, including new product development, registration approvals, and lifecycle management
- Develop and implement regulatory strategies for INDs, NDAs, MAAs, and other regulatory filings
- Manage the PSMA portfolio team, aligning workloads, business objectives, and timelines
- Lead registration strategies and processes in collaboration with cross-functional teams
- Act as regulatory lead for the PSMA portfolio across global regulatory frameworks
- Provide regulatory risk assessments and mitigation plans
- Communicate with applicants and health authorities including FDA, EMA, TGA Australia, CDE China, PMDA Japan, and other local authorities
- Interface with QA, Clinical Development, Research and Innovation, and other functions to ensure timely, compliant dossiers
- Lead regulatory portfolio planning and prioritization
- Advise senior management on regulatory risks and opportunities
- Collaborate with Commercial, Supply Chain, Quality, and Strategic teams
- Manage responses to health authority queries, variations, and post-market compliance requirements
Requirements
- Degree in Life Sciences, Pharmacy, Regulatory Affairs, or a related field (advanced degree preferred)
- 15+ years of experience in Regulatory Affairs, including leadership
- Strong experience in clinical and commercial regulatory submissions, including CTAs, INDs, NDAs, MAAs, and post-market variations
- Expertise in global regulatory frameworks, including FDA, EMA, TGA, PMDA, Health Canada, and Medsafe
- Proven ability to interact with regulatory agencies and lead successful health authority interactions
- Strong knowledge of ICH guidelines, CTD/eCTD submissions, and regulatory lifecycle management
- Ability to develop and implement global regulatory strategies
- Ability to manage cross-functional and regional teams
- Strong communication, collaboration, adaptability, ethical behavior, and continuous learning capabilities
Benefits
- Competitive salaries
- Annual performance-based bonuses
- Equity-based incentive program
- Generous vacation
- Paid wellness days
- Support for learning and development
- Hybrid and remote work arrangements
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