<p>See Yourself at Telix</p> <p>The Manager, GRA - CMC is responsible for authoring/writing CMC specific regulatory dossiers (3.2.S and 3.2.P sections) towards the development and commercialization of radiopharmaceutical and biopharmaceutical products. This role requires good understanding of technical (Quality/CMC) regulatory requirements, and an equally important ability to write technical Module 3 dossiers. The Manager RA CMC will develop ICH aligned CMC/Technical portions of global regulatory submissions that are high-quality, fit for purpose, and prepared in a timely manner across for early to late stage and post-approval programs.</p> <p>Key Accountabilities:</p> <ul> <li>Regulatory Submissions: Plan, prepare/revise eCTD Module 2.3 & Module 3 documents for INDs, IMPDQs, NDAs, BLAs, MAAs, CTAs, post-approval supplements and variation submissions, ensuring accuracy and completeness. </li><li>Documentation and Systems: Ensure Module 3 documentation is planned, tracked, clearly written, with the use of regulatory domain systems (Veeva) and processes. </li><li>Regulatory Compliance and Intelligence: Stay current and interpret evolving CMC regulatory requirements and guidelines such as ICH, US FDA CFRs, EMA Directives and Annexes. Ensure CMC documentation and data are compliant with regulations. </li><li>Cross-Functional Collaboration: Collaborate with internal stakeholders, including Quality Assurance, CMC/Manufacturing, and preclinical teams for planning and authoring of CMC regulatory scope and content. </li><li>Change Management: Provide regulatory assessments for manufacturing changes, including site transfers, scale-up activities, and process changes. Conduct comparability assessments and develop post-approval supplements as needed. </li><li>Risk Management: Identify potential CMC regulatory risks and suggest mitigation plans to proactively manage issues. </li></ul> <p>Education and Experience:</p> <ul> <li>Undergraduate degree required; Advanced degree (M.Sc., Ph.D.) with a focus in Biological Sciences, Engineering or a related field preferred. </li><li>7+ years of experience with a strong focus on CMC in the radiopharmaceutical or biopharmaceutical industry. </li><li>Regulatory Knowledge: Solid understanding of global regulatory requirements and guidelines for CMC, including ICH guidelines and FDA, EMA, and other health authority regulations. </li><li>Communication Skills: Excellent technical writing and verbal communication skills, with the ability to effectively communicate complex regulatory issues to internal and external stakeholders. </li><li>Analytical Skills: Good analytical and problem-solving skills, with the ability to assess and mitigate regulatory risks. </li><li>Interpersonal Skills: Ability to work collaboratively and build effective relationships across functions and geographies. </li><li>Technical Writing: Skilled at summarizing pharmaceutical manufacturing and method development reports, data into appropriate sub-sections of Module 3. </li></ul> <p>Key Capabilities:</p> <ul> <li>Inclusive mindset: Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected </li><li>Results-oriented: Driven to achieve goals and objectives, with a strong focus on delivering measurable results </li><li>Ethical behavior: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders </li><li>Adaptability: Comfortable working in a dynamic environment, adjusting to changing priorities, and taking on new challenges </li><li>Collaboration: Work effectively as part of a team, actively sharing knowledge and expertise to achieve common goals </li><li>Resilience: Demonstrate the ability to bounce back from setbacks and persevere in the face of challenges </li><li>Continuous learning: Show a commitment to ongoing learning and professional development, continually seeking opportunities to expand your knowledge and skills </li></ul>