Director, Technical Regulatory (CMC and Emerging Technologies)

See Yourself at Telix

The Director of Technical Regulatory (Chemistry, Manufacturing, and Controls (CMC) and Emerging Technologies) is responsible for leading and managing all CMC and regulatory activities for the development and commercialization of pharmaceutical products. This role requires a deep understanding of global regulatory requirements and guidance, strong strategic and technical expertise, and the ability to effectively communicate with internal and external stakeholders. The Director will ensure that all global regulatory submissions have CMC dossiers that are high-quality, compliant, and prepared in a timely and strategic manner across projects. Additionally, the Director will lead the development of the company’s regulatory strategy for emerging technologies.

Key Accountabilities:

• Strategic Leadership: Develop and implement technical regulatory (CMC and emerging technology) strategies for development, registration, and post-approval activities to ensure compliance with global regulatory requirements.
• Regulatory Submissions: 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.
• Regulatory Compliance: Monitor and interpret global CMC regulatory requirements and guidelines, ensuring that company practices and documentation are compliant with current regulations.
• Cross-Functional Collaboration: Collaborate with internal stakeholders, including R&D, Quality, Manufacturing, and Commercial teams, to ensure alignment and support for regulatory strategies and submissions.
• Risk Management: Identify potential CMC regulatory risks and develop mitigation strategies to address potential issues proactively.
• 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.
• Team Leadership: Manage, mentor, and develop a team of regulatory CMC professionals, fostering a high-performance culture and ensuring continuous improvement and professional growth.
• Regulatory Intelligence: Stay current with evolving regulatory landscapes, including new guidelines, policies, and trends, and communicate key changes to relevant stakeholders.
• 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.

Education and Experience:

• 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.

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, able to adjust to changing priorities, and willing to 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 out opportunities to expand your knowledge and skills