Global Regulatory Affairs CMC Lead – PSMA

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The Manager, GRA - CMC is responsible for managing CMC specific regulatory activities for the development and commercialization of pharmaceutical products. This role requires excellent understanding of technical (Quality/CMC) regulatory requirements, guidance, the ability to write technical Module 3 dossiers and effectively communicate with internal and external stakeholders. The Manager RA CMC will ensure that all global regulatory submissions have CMC dossiers that are high-quality, compliant, and prepared in a timely manner across projects.

Key Accountabilities

• Regulatory Submissions: 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.
• Regulatory Compliance: 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.
• Cross-Functional Collaboration: Collaborate with internal stakeholders, including R&D, Quality Assurance, Manufacturing, and Commercial teams, to ensure alignment and support for regulatory strategies and submissions.
• Risk Management: Identify potential CMC regulatory risks and develop mitigation plans to proactively manage issues.
• Documentation and Systems: 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.
• Regulatory Agency Interactions: Serve as the primary point of contact for CMC regulatory interactions with global health authorities, preparing teams for meetings and leading discussions.
• Regulatory Intelligence: Stay current with evolving regulatory landscapes, including new guidelines, policies, and trends, and communicate key changes to relevant stakeholders.

Education and Experience:

• Bachelor’s degree required; Advanced degree (Ph.D., or equivalent) in Chemistry, Biological Sciences, Engineering or a related field preferred.
• 7+ years of experience in Regulatory Affairs, with a strong focus on CMC, in the pharmaceutical or biotechnology industry.
• Regulatory Knowledge: Strong knowledge of global regulatory requirements and guidelines for CMC, including ICH guidelines and FDA, EMA, and other health authority regulations.
• Communication Skills: Excellent technical writing and verbal 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: Ability to work collaboratively and build effective relationships across functions and geographies.

Key Capabilities:

• Inclusive mindset: Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected
• Creativity and innovation: Possess a willingness to think outside the box and come up with unique and creative solutions to challenges
• Commitment to excellence: Take pride in your work and consistently strive for excellence in everything you do
• Results-oriented: Driven to achieve goals and objectives, with a strong focus on delivering measurable results
• Ethical behavior: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders
• Adaptability: Comfortable working in a dynamic environment, adjusting to changing priorities, and take on new challenges
• Strong communication skills: Able to communicate effectively with colleagues and stakeholders at all levels, using clear and concise language
• Collaboration: Work effectively as part of a team, actively sharing knowledge and expertise to achieve common goals
• Resilience: Demonstrate the ability to bounce back from setbacks and persevere in the face of challenges
• Continuous learning: Show a commitment to ongoing learning and professional development, continually seeking opportunities to expand your knowledge and skills