Remote Director, Technical Regulatory

Summary

Join Telix Pharmaceuticals, a dynamic and fast-growing radiopharmaceutical company, as the Director of Technical Regulatory (Chemistry, Manufacturing, and Controls (CMC) and Emerging Technologies). This role requires leading and managing all CMC and regulatory activities for the development and commercialization of pharmaceutical products. The ideal candidate will have a deep understanding of global regulatory requirements and guidance, strong strategic and technical expertise, and excellent communication skills.

Requirements

• Bachelor’s degree required; Advanced degree (Ph.D., Pharm.D., or equivalent) in Chemistry, Pharmacy, Biological Sciences, or a related field preferred
• 10+ years of experience in Regulatory Affairs, with a strong focus on CMC, in the pharmaceutical or biotechnology industry
• Proven leadership and management experience, with a track record of building and leading high-performing teams
• Regulatory Knowledge: In-depth knowledge of global regulatory requirements and guidelines for CMC, including ICH guidelines and FDA, EMA, and other health authority regulations
• Communication Skills: Excellent verbal and written communication skills, with the ability to effectively communicate complex regulatory issues to internal and external stakeholders
• Project Management: Strong project management skills, with the ability to manage multiple projects and deadlines in a fast-paced environment
• Analytical Skills: Strong analytical and problem-solving skills, with the ability to assess and mitigate regulatory risks
• Interpersonal Skills: Strong interpersonal skills, with the ability to work collaboratively and build effective relationships across functions and geographies

Responsibilities

• Develop and implement technical regulatory (CMC and emerging technology) strategies for development, registration, and post-approval activities to ensure compliance with global regulatory requirements
• Lead the preparation and review of high-quality CMC regulatory documents, including INDs, NDAs, BLAs, MAAs, CTAs, and post-approval submissions, ensuring accuracy and completeness
• Monitor and interpret global CMC regulatory requirements and guidelines, ensuring that company practices and documentation are compliant with current regulations
• Collaborate with internal stakeholders, including R&D, Quality, Manufacturing, and Commercial teams, to ensure alignment and support for regulatory strategies and submissions
• Identify potential CMC regulatory risks and develop mitigation strategies to address potential issues proactively
• Serve as the primary point of contact for CMC regulatory interactions with global health authorities, preparing teams for meetings and leading discussions
• Manage, mentor, and develop a team of regulatory CMC professionals, fostering a high-performance culture and ensuring continuous improvement and professional growth
• Stay current with evolving regulatory landscapes, including new guidelines, policies, and trends, and communicate key changes to relevant stakeholders
• 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

Benefits

• Competitive salaries
• Annual performance-based bonuses
• Equity-based incentive program
• Generous vacation
• Paid wellness days
• Support for learning and development