Associate Director, Global Regulatory Strategy

Openkrill; United States; Hybrid; USD 180,000 - 250,000; Full time

Job summary

Telix Pharmaceuticals in the United States seeks an Associate Director, Global Regulatory Affairs to lead regulatory activities for clinical and commercial registrations across global markets, with primary focus on the PSMA franchise. You will drive submissions, ensure compliance with FDA, EMA, PMDA, and other authorities, and guide cross-functional teams to optimize market access.

Collaborating with QA, Clinical Development, Research & Innovation and regional teams, you will manage timelines,

Qualifications

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

Responsibilities

• Lead regulatory strategy and planning for PSMA franchise across INDs, NDAs, MAAs.
• Manage PSMA portfolio team, align with business objectives and timelines.
• Provide regulatory risk assessments and mitigation plans.
• Communicate with regulatory authorities (FDA, EMA, TGA, PMDA) effectively.
• Collaborate with QA, Clinical Development, Research and Innovation to meet deadlines.
• Partner with regional teams to ensure ongoing regulatory compliance.

Skills

Regulatory leadership

Regulatory strategy

Cross-functional collaboration

Communication skills

Regulatory risk assessment

Education

Life Sciences/Regulatory Affairs degree

15+ years regulatory experience

Job description

Telix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company with offices in Australia (HQ), Belgium, Japan, Switzerland, and the United States. Our mission is to deliver on the promise of precision medicine through targeted radiation. At our core, we exist to create products that seek to improve the quality of life for people living with cancer and rare diseases. You will be supporting the international roll-out of our approved prostate cancer imaging agent and helping us to advance our portfolio of late clinical-stage products that address significant unmet need in oncology and rare diseases.

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.

At Telix, we believe everyone counts, we strive to be extraordinary, and we pursue our goals with determination and integrity. You will be part of an engaged and supportive group of colleagues who all have a shared purpose: to help people with cancer and rare diseases live longer, better quality lives. Being a Telix employee means being a part of a unique, global, interdisciplinary team working to deliver what's next in precision medicine. We have hybrid and remote employees located all around the world. We offer competitive salaries, annual performance-based bonuses, an equity-based incentive program, generous vacation, paid wellness days and support for learning and development.

Telix Pharmaceuticals is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.

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