Associate Director, Regulatory Affairs – Regulatory Intelligence
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Job Description
Associate Director monitoring global pharmaceutical regulations for Telix Pharmaceuticals, a radiopharmaceutical precision-medicine company. Driving regulatory strategy, intelligence communications, and cross-functional compliance for oncology and rare-disease products.
Responsibilities:
- Monitor, assess, and interpret global regulatory developments affecting drug and device development
- Track updates from regulatory authorities, industry associations, and external intelligence sources
- Maintain and enhance regulatory intelligence databases and tools
- Analyze regulatory guidance, policies, and regulations and communicate actionable impacts to stakeholders
- Partner with Quality on change control processes
- Translate complex regulatory information into actionable insights
- Develop newsletters, alerts, trackers, and periodic reports
- Provide tailored regulatory intelligence analyses for internal inquiries and decision-making
- Lead regulatory intelligence meetings and knowledge-sharing forums
- Coordinate cross-functional discussions with Quality, Pharmacovigilance, Clinical, CMC, and Regulatory Affairs
- Lead public commenting processes and support submissions to regulatory authorities and industry organizations
- Maintain regulatory meetings, workshops, and conference information
- Improve regulatory intelligence processes, systems, tools, SOPs, and work practices
- Manage internal knowledge platforms, including SharePoint, intranet, and the Global Regulatory Affairs Portal
- Contribute regulatory intelligence expertise to cross-functional initiatives and organizational projects
- Manage onboarding and offboarding and provide leadership, coaching, and day-to-day oversight for direct reports
Requirements:
- Bachelor's degree in life sciences, law, public policy, or a related field
- A Master's degree or higher is preferred
- Minimum 8 years’ experience in pharmaceutical regulatory affairs, including 6 years’ experience in regulatory intelligence
- Solid working knowledge of the drug, biologic, and device development process, laws, regulations, and guidelines from FDA, EMA, PMDA, ICH, etc.
- Understanding of major regional and global industry association priorities, such as PhRMA, EFPIA, and JPMA
- Proficiency in regulatory intelligence tools and databases
- Previous interactions with FDA or other health authorities are desirable
- Strong analytical, critical thinking, problem-solving, and decision-making skills
- Ability to work independently and collaboratively
- Strong attention to detail and ability to manage multiple priorities
- Strong communication, adaptability, ethical behavior, and commitment to continuous learning
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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