Associate Director, Regulatory Affairs – Regulatory Intelligence
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Job Description
Regulatory intelligence leader monitoring global rules for Telix Pharmaceuticals, a precision radiopharmaceutical company. Translating regulatory developments into strategies, communications, and cross-functional actions.
Responsibilities:
- Monitor and assess global regulatory environments for changes in laws, regulations, and guidance affecting drug and device development
- Track and evaluate updates from regulatory authorities, industry associations, and external intelligence sources
- Maintain and enhance regulatory intelligence databases and tools
- Analyze regulatory developments and assess their impact on internal processes, development programs, and regulatory strategies
- Deliver timely regulatory updates and actionable insights to stakeholders
- Partner with Quality on change-control processes arising from regulatory changes
- Translate complex regulatory information into clear, actionable insights
- Develop and deliver newsletters, alerts, trackers, and periodic reports
- Respond to internal inquiries with tailored regulatory intelligence summaries and analyses
- Lead regulatory intelligence meetings, training sessions, and knowledge-sharing forums
- Coordinate cross-functional discussions with Quality, Pharmacovigilance, Clinical, CMC, and Regulatory Affairs
- Lead public-commenting processes and support company submissions to regulatory authorities and industry organizations
- Maintain regulatory meetings, workshops, and conference schedules
- Improve regulatory intelligence processes, systems, tools, SOPs, and work practices
- Manage internal knowledge-management 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 of team members 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
- Minimum 8 years’ experience in pharmaceutical regulatory affairs, including 6 years’ experience in regulatory intelligence
- Solid working knowledge of drug, biologic, and device development processes, 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 using regulatory intelligence tools and databases
- Strong analytical, critical-thinking, problem-solving, and decision-making skills
- Ability to work independently with minimal supervision and collaboratively as part of a team
- Strong attention to detail and ability to manage multiple priorities
- Master's degree or higher is preferred
- Previous interactions with FDA or other health authorities are desirable
Benefits:
- 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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