[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

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