Associate Director, Regulatory Affairs – Regulatory Intelligence

🕒 September 28

🇨🇦 Canada – 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 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