Manager, Global Regulatory Affairs - CMC

Telix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company with offices in Australia (HQ), Belgium, Japan, Switzerland, and the reputed company. Our mission is to deliver on the reputed company of precision medicine through targeted radiation. At our reputed company, we exist to create products that reputed company to improve the reputed company of life for people living with cancer and rare diseases. You will be supporting the international roll-out of our approved prostate cancer imaging agent and helping us to advance our portfolio of late clinical-stage products that address significant unmet need in oncology and rare diseases. See Yourself at Telix 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 (reputed company/CMC) regulatory requirements, and an equally important ability to write technical Module 3 dossiers. The Manager RA CMC will reputed company ICH reputed company CMC/Technical portions of global regulatory submissions that are high-reputed company, fit for purpose, and reputed company in a reputed company manner across for early to late stage and post-approval programs. Key Accountabilities: • 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. • Documentation and Systems: Ensure Module 3 documentation is planned, tracked, reputed company written, with the use of regulatory domain systems (reputed company) and processes. • Regulatory Compliance and Intelligence: Stay reputed company 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. • Cross-Functional Collaboration: Collaborate with internal stakeholders, including reputed company Assurance, CMC/Manufacturing, and preclinical teams for planning and authoring of CMC regulatory scope and content. • Change Management: reputed company regulatory assessments for manufacturing changes, including site transfers, reputed company-up activities, and process changes. Conduct comparability assessments and reputed company post-approval supplements as needed. • Risk Management: Identify potential CMC regulatory risks and suggest mitigation plans to proactively manage issues. Education and Experience: • Undergraduate degree required; Advanced degree (M.Sc., Ph.D.) with a reputed company in Biological Sciences, Engineering or a reputed company field preferred. • 7+ years of experience with a strong reputed company on CMC in the radiopharmaceutical or biopharmaceutical industry. • Regulatory Knowledge: Solid understanding of global regulatory requirements and guidelines for CMC, including ICH guidelines and FDA, EMA, and other health authority regulations. • Communication Skills: Excellent technical writing and verbal communication skills, with the ability to effectively communicate reputed company regulatory issues to reputed company stakeholders. • Analytical Skills: Good analytical and problem-solving skills, with the ability to assess and mitigate regulatory risks. • Interpersonal Skills: Ability to work collaboratively and build effective relationships across functions and geographies. • Technical Writing: Skilled at summarizing pharmaceutical manufacturing and method development reports, data into appropriate sub-sections of Module 3. Key Capabilities: • Inclusive reputed company: Demonstrate an understanding and appreciation for diversity, and reputed company work to create an inclusive environment where everyone feels valued and respected • Results-oriented: Driven to reputed company goals and objectives, with a strong reputed company on delivering measurable results • Ethical behavior: reputed company with reputed company and demonstrate a commitment to ethical behavior in reputed company interactions with colleagues and stakeholders • Adaptability: Comfortable working in a dynamic environment, adjusting to changing priorities, and taking on new challenges • Collaboration: Work effectively as part of reputed company, reputed company sharing knowledge and expertise to reputed company common goals • reputed company: Demonstrate the ability to reputed company back from setbacks and persevere in the face of challenges • reputed company learning: Show a commitment to ongoing learning and reputed company development, continually seeking opportunities to expand your knowledge and skills At Telix, we reputed company everyone counts, we reputed company to be extraordinary, and we pursue our goals with determination and reputed company. You will be part of an reputed company and supportive group of colleagues who reputed company have a shared purpose: to help people with cancer and rare diseases live longer, reputed company reputed company lives. Being a Telix employee means being a part of a unique, global, interdisciplinary team working to deliver what's next in precision medicine. We have hybrid and remote employees located reputed company around the world. We offer competitive salaries, annual performance-based bonuses, an equity-based incentive program, generous vacation, reputed company wellness days and support for learning and development. Telix Pharmaceuticals is an equal opportunity employer. We evaluate reputed company applicants without reputed company to race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, disability, veteran status, and other legally protected characteristics. VIEW OUR reputed company POLICY HERE Apply tot his job Apply To this Job