Manhattan WMOS Engineer
ShyftLabs
Support Manhattan WMOS implementations and operations as a WMS Engineer at ShyftLabs. ShyftLabs builds data products and digital solutions for Fortune 500 companies.
Open
Telix Pharmaceuticals Limited is a commercial-stage biopharmaceutical company developing and commercializing theranostic radiopharmaceuticals for cancer and rare diseases. Its approach combines targeted imaging with radiation-based treatment to support more informed clinical decisions and personalized care.
The company’s pipeline spans prostate and kidney cancer, neuro-oncology, and musculoskeletal cancers. Telix has secured global regulatory approvals for its lead imaging product, Illuccix®, and continues to advance a broad program of clinical trials worldwide. Its team works across healthcare, biotechnology, and related commercial disciplines to bring radiopharmaceutical innovations from development into clinical use.
Senior Manager, Global Regulatory Strategy (Remote, United States)
Lead global regulatory strategy for Telix’s precision-medicine radiopharmaceutical portfolio. Manage early-stage submissions and health-authority engagement across international markets.
Description
- Lead regulatory activities for an assigned early-stage portfolio across global markets
- Implement global regulatory strategies for assigned assets
- Plan and deliver submissions from IND/CTA through early registration
- Provide regulatory expertise across early-stage development programs
- Plan and coordinate health-authority interactions
- Support the VP, Global Regulatory Strategy, with global planning and cross-functional initiatives
- Create submission plans, timelines, and content requirements
- Support registration strategies and oversee registration processes
- Develop briefing packages and supporting materials for health-authority meetings
- Document meeting minutes and draft responses to agency questions
- Engage with the FDA, EMA, TGA, PMDA, and other health authorities
- Collaborate with QA, Clinical Development, Research & Innovation, and other functions to assemble compliant, timely dossiers
- Advise project teams on regulatory matters
- Assess regulatory risks and recommend mitigation strategies
- Track changes to global health-authority regulations and guidelines
- Manage responses to health-authority queries, variations, and post-approval obligations
Requirements
- Bachelor’s degree in life sciences, pharmacy, regulatory affairs, or a related discipline; an advanced degree is preferred
- At least eight years of Regulatory Affairs experience, including substantial early-stage IND/CTA submission work
- Demonstrated experience with clinical regulatory submissions, including CTAs and INDs, during early-stage development
- Working knowledge of regulatory frameworks covering the FDA, EMA, TGA, PMDA, Health Canada, and Medsafe
- Experience preparing for and supporting interactions with health authorities
- Strong command of ICH guidelines and CTD/eCTD submission requirements
- Understanding of the end-to-end regulatory lifecycle
- Strong communication, collaboration, adaptability, ethical conduct, and commitment to continuous learning
Benefits
- Annual performance-based bonus opportunities
- Equity-based incentive program
- Generous vacation allowance
- Paid wellness days
- Learning and professional development support
- Competitive salary
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