[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 fieldBenefits• Annual performance-based bonuses• Equity-based incentive program• Generous vacation• Paid wellness days• Support for learning and developmentCompany 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