[Remote] Manager, Global Regulatory Affairs - CMC

Note: The job is a remote job and is open to candidates in USA. Telix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company focused on precision medicine. The Manager, GRA - CMC will be responsible for authoring CMC specific regulatory dossiers and ensuring compliance with regulatory requirements for the development and commercialization of radiopharmaceutical and biopharmaceutical products. Responsibilities • 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 • Ensure Module 3 documentation is planned, tracked, clearly written, with the use of regulatory domain systems (Veeva) and processes • 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 • Collaborate with internal stakeholders, including Quality Assurance, CMC/Manufacturing, and preclinical teams for planning and authoring of CMC regulatory scope and content • 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 • Identify potential CMC regulatory risks and suggest mitigation plans to proactively manage issues Skills • Undergraduate degree required • 7+ years of experience with a strong focus on CMC in the radiopharmaceutical or biopharmaceutical industry • Solid understanding of global regulatory requirements and guidelines for CMC, including ICH guidelines and FDA, EMA, and other health authority regulations • Excellent technical writing and verbal communication skills, with the ability to effectively communicate complex regulatory issues to internal and external stakeholders • Good analytical and problem-solving skills, with the ability to assess and mitigate regulatory risks • Ability to work collaboratively and build effective relationships across functions and geographies • Skilled at summarizing pharmaceutical manufacturing and method development reports, data into appropriate sub-sections of Module 3 • Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected • Driven to achieve goals and objectives, with a strong focus on delivering measurable results • Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders • Comfortable working in a dynamic environment, adjusting to changing priorities, and taking on new challenges • Work effectively as part of a team, actively sharing knowledge and expertise to achieve common goals • Demonstrate the ability to bounce back from setbacks and persevere in the face of challenges • Show a commitment to ongoing learning and professional development, continually seeking opportunities to expand your knowledge and skills • Advanced degree (M.Sc., Ph.D.) with a focus in Biological Sciences, Engineering or a related field Benefits • Annual performance-based bonuses • Equity-based incentive program • Generous vacation • Paid wellness days • Support for learning and development Company Overview • Telix is a biopharmaceutical company focused on the development and commercialisation of therapeutic and diagnostic ('theranostic') radiopharmaceuticals. It was founded in 2015, and is headquartered in Melbourne, Victoria, AUS, with a workforce of 1001-5000 employees. Its website is Apply tot his job Apply tot his job