Global Regulatory Affairs CMC Lead

Summary

Join Telix Pharmaceuticals, a fast-growing radiopharmaceutical company, as the Manager, GRA - CMC. You will manage CMC regulatory activities for pharmaceutical product development and commercialization. This role demands expertise in technical regulatory requirements, technical writing (Module 3 dossiers), and effective communication. You will ensure high-quality, compliant global regulatory submissions. The position involves collaboration with internal stakeholders and external health authorities. Telix offers a supportive environment and competitive benefits.

Requirements

• Hold a Bachelor’s degree
• Have 7+ years of experience in Regulatory Affairs, with a strong focus on CMC, in the pharmaceutical or biotechnology industry
• Possess strong knowledge of global regulatory requirements and guidelines for CMC, including ICH guidelines and FDA, EMA, and other health authority regulations
• Demonstrate excellent technical writing and verbal communication skills, with the ability to effectively communicate complex regulatory issues to internal and external stakeholders
• Possess strong project management skills, with the ability to manage multiple projects and deadlines in a fast-paced environment
• Demonstrate strong analytical and problem-solving skills, with the ability to assess and mitigate regulatory risks
• Have the ability to work collaboratively and build effective relationships across functions and geographies

Responsibilities

• Plan, prepare and review CMC Module 2.3 & Module 3 documents for INDs, IMPDQs, NDAs, BLAs, MAAs, CTAs, and post-approval supplements and variation submissions, ensuring accuracy and completeness
• Monitor and interpret global CMC regulatory requirements and guidelines such as ICH, US FDA CFRs, EMA Directives and Annexes, ensuring that company practices and documentation are compliant with current regulations
• Collaborate with internal stakeholders, including R&D, Quality Assurance, Manufacturing, and Commercial teams, to ensure alignment and support for regulatory strategies and submissions
• Identify potential CMC regulatory risks and develop mitigation plans to proactively manage issues
• Ensure that regulatory CMC documentation is managed efficiently, and that systems and processes are in place for the proper archiving and retrieval of regulatory documents
• Serve as the primary point of contact for CMC regulatory interactions with global health authorities, preparing teams for meetings and leading discussions
• Stay current with evolving regulatory landscapes, including new guidelines, policies, and trends, and communicate key changes to relevant stakeholders

Preferred Qualifications

Hold an Advanced degree (Ph.D., or equivalent) in Chemistry, Biological Sciences, Engineering or a related field

Benefits

• Competitive salaries
• Annual performance-based bonuses
• An equity-based incentive program
• Generous vacation
• Paid wellness days
• Support for learning and development
• Hybrid and remote work options