Note: The job is a remote job and is open to candidates in USA. Telix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company committed to precision medicine. The Associate Director of Regulatory Affairs Operations will lead the execution of regulatory operational activities, ensuring timely and compliant delivery of global regulatory submissions while managing a small team and collaborating with cross-functional stakeholders.
Responsibilities
- 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 being a partner in 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
Skills
- 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
- 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 (e.g., CTD/eCTD structure, format, and submission requirements, and proficiency in MS Word (e.g., authoring templates), Adobe Acrobat, electronic publishing software, and document management systems (e.g., CSC Toolbox, Lorenz DocuBridge, or equivalent); advanced or expert-level knowledge is an advantage
- Strong leadership, organizational, cross-functional communication, and project management skills, with the ability to manage multiple priorities simultaneously and assess the impact of changes on project timelines
- Ability to work effectively in a collaborative, fast-paced, mid-size company environment
- Fluency in English (spoken, written, and reading)
- Experience managing with and/or overseeing external publishing service providers for regulatory submissions is desirable
- Proficiency in an additional European language is an asset
Benefits
- Annual performance-based bonuses
- An equity-based incentive program
- Generous vacation
- Paid wellness days
- Support for learning and development
- Hybrid and remote employees located all around the world
Company Overview