Translational Regulatory Affairs Director
hace 3 semanas
Location: Barcelona (on-site) 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 Translational Regulatory Affairs Director (RAD) provides strategic and regulatory leadership to the development, commercialisation, and life cycle management of assigned product(s) with a specific focus on translational areas. Translational areas are development opportunities that take place in cross-functional teams and focus on biomarkers or approaches such as the development of novel endpoints, in vitro diagnostics (IVDs), regulatory innovations, or the introduction of digital therapeutics in development programs. This requires early anticipation of the potential regulatory impact and developing capabilities to design regulatory strategies applicable to late development projects, which meet regulatory agencies' requirements. The Translational RAD 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 or through an ongoing development program. The Translational RAD plays a key role in working closely with the RADs and other AZ functions assigned to development programs and contributes to product development by facilitating successful regulatory submissions in biomarker-driven programs, including IVDR.
In this role, you will be responsible for developing, aligning, and implementing regulatory strategies to ensure successful submissions and approvals with target labels for assigned biomarker-driven development projects on a global scale. The ideal candidate has expertise in IVDR requirements and will be responsible for coordinating IVDR submission activities with internal and external stakeholders. The successful candidate will work closely within cross-functional teams to ensure that regulatory requirements of the biomarker and IVDs in oncology clinical trials, especially innovative biomarkers and technologies (e.g., ctDNA, computational pathology, AI/ML), are met throughout the biomarker development process. 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.
Typical Accountabilities, What You will be Doing Lead the development of global regulatory strategies, including IVDR, to facilitate the advancement of innovative biomarkers and associated IVD technologies. Collaborate with project teams and other functions as necessary to ensure seamless integration of these elements into regulatory risk assessment and mitigation strategies.Develop and implement regulatory strategies to support the clinical development of biomarkers and IVDs, ensuring alignment with organizational objectives.Coordinate IVDR activities for biomarker-driven drug programs, including review of submission documents and organizing meetings with internal project teams and IVDR vendors.Work closely within cross-functional teams, actively participating in decision-making processes related to biomarker and assay-driven drug development queries.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.Engage with major health authorities to optimize regulatory strategies and maintain productive relationships.Organize and lead preparations for meetings and teleconferences with local and global health authority officials, focusing on biomarker and innovation-related topics.Keep abreast of relevant regulatory policies and guidelines, understanding their implications for clinical and scientific practices.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 Essential Advanced degree in life sciences or a related field, such as Ph.D., Pharm.D., or M.Sc.Minimum of 5 years of experience in regulatory affairs or a closely related field.Expertise in biomarkers and IVD/companion diagnostic (CDx) regulations, including IVDR, with a thorough understanding of global regulatory frameworks.RVDR experience.Knowledgeable about biomarker innovations in oncology drug development, such as the use of AI/ML and digital measurement tools.Proven track record of regulatory co-development of companion diagnostics with therapeutic products, with experience in engaging with major health authorities.Solid understanding of regulatory affairs in oncology throughout both early and late-stage development.Demonstrated competencies in strategic thinking, internal and external influencing, innovation, initiative, leadership, and exceptional oral and written communication skills.Strong abilities in communication, negotiation, and problem-solving.Proficiency in working effectively within cross-functional teams and managing multiple priorities.Excellent organizational and project management abilities, with keen attention to detail.Capacity to work autonomously while maintaining high-quality standards. Desirable Ability to work strategically within innovative, complex, business critical and high-profile development programs.Prior experience with oncology regulatory affairs; understand the strategic and tactical roles and deliverables of global regulatory strategy in oncology drug development.Technical experience and understanding of biomarker innovations such as use of AL/ML computational pathology, or digital health would be advantageous.
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