Technical – CMC

See Yourself at Telix

We are seeking an experienced Technical (CMC) Writer in Regulatory Affairs. This position offers a unique opportunity to contribute to the achievement of Telix’s strategic goals by leading and driving the technical (CMC) regulatory writing to accelerate the development of diagnostic and therapeutic assets in areas of high unmet medical need.

This role will lead the preparation of the quality/CMC sections of the regulatory module 3 dossier and associated information in agency briefing books using internal manufacturing and quality source documentation.

The Technical Regulatory Writer will identify, engage, and project manage the work of contract technical writers as required.

Key Accountabilities:

• Lead the compilation, writing, and editing of high-quality module 3 documents.
• Develop and update pertinent SOPs, processes, templates, style guides, and manuals, as needed.
• Maintain working knowledge of the Telix development pipeline.
• Prepare, review, and edit regulatory submission documents (e.g., INDs, NDAs, BLAs, CTDs).
• Ensure all documents comply with regulatory guidelines, company standards, and industry best practices.
• Lead and manage multiple regulatory technical writing projects simultaneously, ensuring timely delivery of high-quality documents.
• Coordinate with cross-functional teams to gather necessary information and resolve any issues that arise during the document development process.
• Conduct thorough reviews of documents for accuracy, consistency, and clarity as needed.
• Work closely with clinical development teams, including clinical operations, regulatory affairs, biostatistics, physicians, and medical affairs, to ensure alignment and accuracy of clinical documents.
• Provide medical writing expertise and support to project teams, contributing to strategic planning and decision-making.
• Mentor and train junior medical writers, providing guidance and support to enhance their skills and career development, along with oversight to external contractors.
• Stay current with industry trends, guidelines, and best practices, and share knowledge with the team.
• Support regulatory submissions by preparing high-quality documentation and addressing health authority comments and queries.
• Ensure compliance with regulatory requirements and timelines for all submission-related activities.

Education and Experience:

• Bachelor’s degree in a scientific or related field required; MS or PhD preferred.
• 5+ years’ overall experience in technical/CMC writing, 2+ years within Regulatory CMC required
• Experience overseeing and mentoring contractors and junior team members strongly preferred
• Strong understanding of drug development, drug substance and drug product manufacturing, regulations (CFR, FDA, EMA, and ICH guidelines), and scientific principles.
• Experience and proficiency with document templates, document toolbars and proper version control.
• Strong project management skills. Organized and self-motivated. Strong attention to detail.

Key Capabilities:

• Inclusive mindset: Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected
• Creativity and innovation: Possess a willingness to think outside the box and come up with unique and creative solutions to challenges
• Commitment to excellence: Take pride in your work and consistently strive for excellence in everything you do
• Results-oriented: Driven to achieve goals and objectives, with a strong focus on delivering measurable results
• Ethical behavior: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders
• Adaptability: Comfortable working in a dynamic environment, able to adjust to changing priorities, and willing to take on new challenges
• Strong communication skills: Able to communicate effectively with colleagues and stakeholders at all levels, using clear and concise language
• Collaboration: Work effectively as part of a team, actively sharing knowledge and expertise to achieve common goals
• Resilience: Demonstrate the ability to bounce back from setbacks and persevere in the face of challenges
• Continuous learning: Show a commitment to ongoing learning and professional development, continually seeking out opportunities to expand your knowledge and skills