Associate Director, Global Regulatory Strategy

See Yourself at Telix

To support the Group’s strategic objectives, the Associate Director, Global Regulatory Affairs (GRA) will lead regulatory activities for clinical and commercial registrations across global markets. This role is responsible for the overall management of the PSMA franchise, including regulatory oversight for PSMA-related products, encompassing new product development, registration approvals, and lifecycle management. The Associate Director will play a key role in providing comprehensive regulatory support for the PSMA franchise globally. This includes leading regulatory submissions, ensuring compliance with international requirements, and aligning regulatory strategies to facilitate successful market access. Additionally, the role will support the Senior Director, GRS in managing global regulatory projects and strategic initiatives

Key Accountabilities:

• Regulatory Strategy and Planning - Develop and implement regulatory strategies for clinical, commercial, and lifecycle management of PSMA Franchise Plan submissions for INDs, NDAs, MAAs, or other relevant regulatory filings in collaboration with cross-functional teams.
• Manage the PSMA portfolio team, ensuring alignment with business objectives, balanced workload distribution, and adherence to timelines.
• Develop and implement regulatory strategies to support new product development, registrations, and post-approval changes across the PSMA portfolio.
• Assist in developing registration strategies and managing the registration process through collaboration with cross-functional teams for PSMA franchise.
• Act as the regulatory lead for PSAM portfolio, ensuring alignment with global regulatory frameworks (e.g., FDA, EMA, TGA, PMDA etc.,).
• Provide regulatory risk assessments and mitigation plans to optimize submission timelines and regulatory success for PSMA franchise.
• Communication with Regulatory Authorities - Efficient communication with the applicants, strategies preparation and presentation for institutions (e.g. FDA, EMA, TGA Australia, CDE China, PMDA-Japan and other local health authorities from the region).
• Interfacing internally with QA, Clinical Development, Research and Innovation and other functions involved to ensure that dossiers are presented within the scheduled deadlines and that the material provided meets regulatory
• Lead regulatory portfolio planning and prioritization, ensuring alignment with corporate and commercial
• Provide expert advice to senior management on regulatory risks and opportunities related to PSMA
• Collaborate closely with regional teams, including Commercial, Supply Chain, Quality, and Strategic teams, to manage ongoing business commitments while ensuring compliance with the latest regulatory requirements.
• Manage responses to Health Authority queries, variations, and post-market compliance requirements for PSMA portfolio

Position Requirements

Education and Experience:

• Degree in Life Sciences, Pharmacy, Regulatory Affairs, or a related field (advanced degree preferred).
• 15+ years of experience in Regulatory Affairs, including leadership
• Strong experience in clinical and commercial regulatory submissions (CTAs, INDs, NDAs, MAAs, post-market variations).
• Expertise in global regulatory frameworks (FDA, EMA, TGA, PMDA, Health Canada, Medsafe).
• Proven ability to interact with regulatory agencies and lead successful health authority
• Strong knowledge of ICH guidelines, CTD/eCTD submissions, and regulatory lifecycle

Key Capabilities:

• 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
• Creativity and innovation: Possess a willingness to think outside the box and come up with unique and creative solutions to 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
• Inclusive mindset: Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected
• Adaptability: Comfortable working in a dynamic environment, able to adjust to changing priorities, and willing to take on new challenges
• Ethical behavior: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders
• Continuous learning: Show a commitment to ongoing learning and professional development, continually seeking out opportunities to expand your knowledge and skills