International Regulatory Affairs Director

As the Regulatory Affairs Director at AstraZeneca, you will play a crucial role in developing and implementing international regulatory strategies for a group of products. Your responsibilities will include: - Developing and implementing innovative international regulatory strategies to ensure rapid approval with advantageous labeling. - Leading the development, communication, and updates of the International section of the Regulatory Strategy Document (RSD) for assigned products/projects. - Ensuring appropriate cross-functional coordination with International Commercial, peer review, and senior team member endorsement from ILT and GPT. - Attaining regulatory breakthroughs by evaluating the likelihood of success 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 implementing an optimal regional regulatory strategy for products to ensure rapid market access. - Providing regulatory leadership in various aspects such as in-license/due diligence review, product divestment, and product withdrawal. - Partnering with marketing company staff to monitor changes in the regulatory environment and influencing developing views/guidance within leading Health Authorities. 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, and work within a complex, high-profile development program. - Strong cross-cultural awareness and excellent oral and written communication skills. Desirable skills/experience include: - Strong commercial awareness. - Subject Matter Expertise in International strategy and tactical delivery. AstraZeneca values diversity, equality of opportunity, and inclusion. We are committed to building an inclusive and diverse team representing all backgrounds to foster collaboration and innovation. If you are ready to make a difference and be part of a team that sets new directions for patient care, apply now to join our dynamic team at AstraZeneca.,