Associate Director, Regulatory Affairs – Operations

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Telix Pharmaceuticals Limited

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2015

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

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

• Lead the planning, coordination, and execution of global regulatory submissions (e.g., INDs, CTAs, NDAs, BLAs, MAAs, and amendments), ensuring compliance with global regulatory requirements and timelines. • Provide operational oversight of eCTD submission activities, partnering with external publishing vendors and internal stakeholders to ensure high-quality, timely deliverables. • In partnership with the Senior Director of Regulatory Operations, play a key role in establishing internal publishing capabilities, including defining and leading implementation of publishing capability strategy • Ensure accurate maintenance of regulatory documentation, submission records, and data within regulatory information management and document management systems. • Oversee regulatory document management, tracking, and archival processes to ensure completeness, accuracy, and inspection readiness. • Serve as system administrator for regulatory systems (e.g., Veeva RIM) and act as the internal subject matter expert (SME), driving training, user adoption, and ongoing support in alignment with the defined system strategy and roadmap. • Ensure adherence to global submission standards, including eCTD structure, formatting, and publishing requirements. • Drive the development and continuous improvement of regulatory operations processes, tools, and best practices to enhance efficiency, quality, and consistency. • Lead, mentor, and develop a small team of regulatory operations staff, fostering a high-performing and collaborative team environment. • Oversee vendor relationships and outsourced publishing activities, ensuring performance, quality, and cost-effectiveness. • Partner with Regulatory Affairs leads to operationalize global submission strategies. • Collaborate cross-functionally with clinical, quality, and CMC teams to ensure alignment and execution of submission plans. • Monitor submission milestones and deliverables, proactively identifying risks and driving mitigation strategies to prevent delays. • Ensure ongoing compliance with global regulatory standards and organizational policies. • Maintain inspection readiness and support internal and external audits. • Ensure integrity, accuracy, and completeness of regulatory records and documentation. • Manage submission timelines, milestones, and deliverables across programs. • Lead risk assessment, escalation, and resolution to ensure successful execution of regulatory activities.

🎯 Requirements

• Bachelor’s degree in Life Sciences or a related discipline is required. • Minimum of 9 years of relevant experience in Regulatory Affairs or Regulatory Operations within the pharmaceutical or biotechnology industry, including demonstrated leadership experience of at least 2 years. • Experience with Regulatory Information Management Systems (RIMS), Electronic Document Management Systems (EDMS), and electronic publishing tools; experience with Veeva Vault Regulatory is required. • Strong working knowledge of the drug development process and global regulatory frameworks. • Experience managing with and/or overseeing external publishing service providers for regulatory submissions is desirable. • Advanced proficiency with Microsoft Office Suite (Word, Excel, PowerPoint) and collaboration tools such as Microsoft Teams. • Experience using project planning and tracking tools (e.g., Smartsheet, Microsoft Project, or similar) to support regulatory timelines and deliverables. • Strong Knowledge of global regulatory submission standards and requirements, including FDA, EMA, ICH guidelines, and eCTD submission formats. • Expertise in eCTD publishing and lifecycle management • Deep knowledge of global regulatory submission requirements.

🏖️ Benefits

• Competitive salaries • Annual performance-based bonuses • Equity-based incentive program • Generous vacation • Paid wellness days • Support for learning and development