Associate Director, Regulatory Affairs – Regulatory Intelligence

Job not on LinkedIn

🔥 2 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

🚔 Compliance

👻 Ghost score 10%

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Telix Pharmaceuticals Limited

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2015

🏥 Healthcare

💼 Consulting

🧬 Biotechnology

Healthcare • Consulting • Biotechnology

Telix Pharmaceuticals Limited is a commercial-stage biopharmaceutical company dedicated to transforming the way cancer and rare diseases are diagnosed and treated. Focusing on the development and commercialization of theranostic radiopharmaceuticals, Telix utilizes targeted radiation to enhance treatment decision-making and deliver personalized therapy. With an extensive pipeline addressing areas such as prostate and kidney cancer, neuro-oncology, and musculoskeletal cancers, Telix has garnered global regulatory approvals for its lead imaging agent, Illuccix®, and is actively conducting numerous clinical trials worldwide.

📋 Description

• 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