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Senior Manager, Global Regulatory Strategy
Telix Pharmaceuticals LimitedSenior Manager for Global Regulatory Strategy at Telix Pharmaceuticals. Leading regulatory strategies for oncology and radiopharmaceutical products with cross-functional collaboration.
About the role
Key responsibilities & impact- Support the development and execution of regulatory strategies for assigned portfolio assets, ensuring alignment with program objectives and global regulatory requirements
- Contribute to regulatory planning for new product development, global submissions, and lifecycle management activities across pipeline and commercial assets
- Partner cross-functionally to help align regulatory strategies with clinical, CMC, and commercial plans
- Maintain awareness of global regulatory frameworks (e.g., FDA, EMA, TGA, PMDA, CDE) and apply them to program-level strategy and execution
- Identify regulatory risks and support development of mitigation plans in collaboration with senior regulatory leadership
- Lead the preparation for Health Authority interactions and submissions, including preparation of briefing documents, dossiers and other documentation in alignment with regulatory requirements
- Manage responses to Health Authority queries and support regulatory milestone deliverables
- Ensure documentation and communications are complete, accurate, and aligned with agreed regulatory strategies
- Serve as the regulatory lead on assigned R&D project teams and partner cross-functionally with Clinical, Quality, CMC, Commercial, non-clinical and regulatory functions
- Provide input and recommendations on regulatory risks, opportunities, and implications across the global portfolio
Requirements
What you’ll need- Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, Regulatory Affairs, or related scientific field required
- 8+ years of experience within pharmaceuticals, biotech, or life sciences
- 5+ years of experience in Regulatory Affairs
- Strong background in regulatory strategy for oncology or radiopharmaceutical products is highly desirable
- Proven experience with global regulatory frameworks (e.g., FDA, EMA, TGA, PMDA, CDE)
- Prior experience contributing to health authority interactions (briefing support, responses, documentation)
- Experience working on cross-functional teams (Clinical, CMC, Quality, etc.)
- Solid understanding of drug development process and regulatory requirements across development and commercialization
- Ability to translate regulatory guidance into program-level actions
- Strong project management and organizational skills; able to manage multiple priorities
- Effective cross-functional collaboration and communication skills
- Ability to identify risks and escalate appropriately, with sound judgment.
Benefits
Comp & perks- Competitive salaries
- Annual performance-based bonuses
- Equity-based incentive program
- Generous vacation
- Paid wellness days
- Support for learning and development
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
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Hard Skills & Tools
regulatory strategyregulatory affairsglobal regulatory frameworksdrug development processoncology productsradiopharmaceutical productshealth authority interactionsregulatory documentationrisk identificationproject management
Soft Skills
cross-functional collaborationcommunication skillsorganizational skillsability to manage multiple prioritiessound judgment
Certifications
Bachelor’s degree in Life SciencesBachelor’s degree in PharmacyBachelor’s degree in ChemistryBachelor’s degree in Regulatory Affairs