International Regulatory Affairs Director

As the Regulatory Affairs Director at AstraZeneca, your role involves developing and implementing international regulatory strategies for a group of products. Your responsibilities include: - Developing innovative international regulatory strategies to ensure rapid approval with advantageous labeling. - Leading the communication and updates of the International section of the Regulatory Strategy Document (RSD). - Coordinating cross-functionally with International Commercial, peer review, and senior team members. - Assessing emerging data against aspirations, updating senior management on project risks, and implementing risk mitigation measures. - Serving as the single point of contact and Regional Regulatory Affairs representative on Regional Product Teams. - Leading the planning and construction of the International dossier and ensuring effective regulatory representation at health authority meetings. - Leading regulatory staff working on a product/project to deliver prioritized objectives on time and with quality. - Participating in skill development, coaching, and performance feedback of other regulatory staff. - Partnering with marketing company staff to monitor changes in the regulatory environment and support Global Product Teams (GPT) or ILT accordingly. - Influencing developing views/guidance within leading Health Authorities on specific topics relevant to projects or regulatory matters. Qualifications required for this role include: - Bachelor's degree in a science-related field or equivalent experience. - Previous experience in attending and/or helping a team prepare for Major Health Authority interactions. - Extensive experience in regulatory drug development, including product approval/launch. - Proven leadership and program management experience. - Ability to think strategically, critically evaluate risks to regulatory activities, and work within a complex, high-profile development program. Desirable skills/experience: - Strong commercial awareness. - Subject Matter Expertise in International strategy and tactical delivery. At AstraZeneca, we foster a diverse and inclusive environment where every voice is valued, promoting open communication and powerful innovation. Join our team to make a difference in patient care and contribute to bringing transformative drugs to those in need. Apply now to be part of our dynamic team and embrace the opportunity to work in a unique and ambitious environment, balancing office work with individual flexibility. Join AstraZeneca and be part of a team that sets new directions for patient care and innovation in the pharmaceutical industry. Date posted: 18-Jun-2025 Closing Date: 29-Jun-2025 AstraZeneca is committed to diversity, equality of opportunity, and building an inclusive team representing all backgrounds. We welcome applications from all qualified candidates, regardless of their characteristics, in compliance with non-discrimination laws and regulations.,