Translational Regulatory Affairs Director
AstraZeneca
- Barcelona
- Permanente
- Tiempo completo
- 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.
- 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.
- 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.
- 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.