Director of Translational Regulatory Science

Are you a strategically focused Regulatory professional who would like to play an integral part in bringing life changing Oncology medicines to patients? If so, please join us

At AstraZeneca, we work with diverse minds, all united by a shared passion to learn, grow and discover.

Within Oncology Regulatory Science, Strategy & Excellence (ORSSE), we bring hope and solutions to patients across the globe. As Regulatory professionals working on Oncology products, we work in areas of unmet need and take innovative regulatory approaches to bring life-changing treatments to patients. We work across our pipeline and the business to get medicines to patients as efficiently and effectively as possible.

The Director of Translational Regulatory Science provides strategic and regulatory leadership to the development, commercialization, and life cycle management of assigned product(s) with a specific focus on translational areas. This requires early anticipation of the potential regulatory impact and developing capabilities to design regulatory strategies applicable to early and late development projects, which meet regulatory agencies’ requirements. The role interfaces between the functional areas involved in these projects, participates in the projects as a team member, and helps identify all necessary regulatory aspects that may benefit from interactions with regulatory authorities in both early and late stages of development. This position plays a key role in working closely with the Regulatory Affairs Directors (RADs) assigned to development programs and contributes to product development by organizing regulatory authority interactions dedicated to focused topics to be an integral part of a development program.

In this role, you will be responsible for developing, aligning, and implementing regulatory strategies to ensure successful early and late Oncology development projects on a global scale. You will serve as the global regulatory lead (GRL) on early-stage projects or specific indications of larger programs and/or as the regional regulatory lead. The successful candidate will work closely within cross-functional teams to ensure that regulatory requirements in Oncology clinical trials, including those for innovative biomarkers, technologies (e.g., ctDNA, computational pathology, AI/ML), and therapeutics are met throughout the drug development process. The Director of Translational Regulatory Science plays a substantial role crafting and implementing the clinical strategy and influencing health authorities to improve outcomes.The impact and visibility of this position are high, with implications for regulatory decisions, timelines, and advancement for the company in contributing to the ORSSE "Roadmap" implementation.

If you are a Regulatory professional with a passion for Oncology and want to make a difference in the lives of cancer patients, please apply to join our team at AstraZeneca.

What You will be Doing:

1. Lead the development of global regulatory strategies to facilitate the advancement of early and late Oncology programs, including those that involve innovative biomarkers, technologies, and therapeutics. Collaborate with project teams and other functions as necessary to ensure seamless integration of these elements into regulatory risk assessment and mitigation strategies.
2. Lead cross-functional teams in major regulatory submissions (NDA/BLA/IND/CTA), health authority interactions, label discussions, and securing approvals.
3. Develop and implement regulatory strategies to support the clinical development of Oncology therapeutic products, ensuring alignment with organizational objectives.
4. Serve as the Regulatory Affairs representative on designated global project teams, offering strategic insights and guidance on key development and regulatory documents. Oversee the review process, ensuring scientific coherence and compliance with regional and global regulations.
5. Engage with major health authorities to optimize regulatory strategies and maintain productive relationships.
6. Organize preparations for meetings and teleconferences with local and global health authority officials, focusing on biomarker and innovation-related topics.
7. Keep abreast of relevant regulatory policies and guidelines, understanding their implications for clinical and scientific practices.
8. Drive opportunities for external engagement, contributing to relevant publications and participating in external speaking events to enhance the company's visibility and influence in the regulatory landscape.

Education, Qualifications, Skills, and Experience:

1. Advanced degree in life sciences or a related field, such as Ph.D., Pharm.D., or M.Sc.
2. Minimum of 5 years of experience in regulatory affairs or a closely related field.
3. Expertise in therapeutic product regulations, with a thorough understanding of global regulatory frameworks.
4. Understanding of regulatory affairs in Oncology throughout both early- and late-stage development.
5. Demonstrated competencies in strategic thinking, internal and external influencing, innovation, initiative, leadership, and exceptional oral and written communication skills.
6. Strong abilities in communication, negotiation, and problem-solving.
7. Proficiency in working effectively within cross-functional teams and managing multiple priorities.
8. Excellent organizational and project management abilities, with keen attention to detail.
9. Capacity to work autonomously while maintaining high-quality standards.
10. Experience in Oncology (small molecules & biologics) is preferred.

1. Prior experience with phase 3 design including end of phase 2 health authority interactions.
2. Contribution to a regulatory approval including leading response team and labelling negotiation.
3. Knowledge and understanding of guiding principles in drug development such as benefit/risk profile, dose selection or statistical design.
4. Broad background of experience working in pharmaceutical business and prior experience in several areas within regulatory affairs.
5. Ability to work strategically within innovative, complex, business critical and high-profile development programs.
6. Critical thinking on current global regulatory science questions and good understanding of the corresponding scientific and clinical component.
7. Technical experience and understanding of biomarker innovations such as use of AL/ML computational pathology, or digital health would be advantageous.

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn't mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

Why AstraZeneca?

Join a talented global team that's powering AstraZeneca to better serve patients, every day. The fuel behind our evolving, rapidly growing enterprise, we're here to help unlock the power of what science can do and ultimately have a big impact on patients' lives. Integrated and closely aligned with the whole enterprise, we offer our expertise, and leverage exciting new technology and digital innovations, to accelerate AstraZeneca's evolution. We do all of it strategically, looking ahead to the new challenges we'll face and improving the way the enterprise operates today.

SO, WHAT’S NEXT?

To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.

Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. Our head office is purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects.

Great People want to Work with us Find out why:

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AstraZeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested.