Director International Regulatory Policy and Intelligence

منذ 2 أيام

Sharjah city, Sharjah, الإمارات العربية المتحدة AstraZeneca دوام كامل
Director International Regulatory Policy and Intelligence (International Regulatory Affairs) MEA & Eurasia AstraZeneca is a global science‐led patient‐focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of the world's most serious diseases. We are more than one of the world's leading pharmaceutical companies. Role Summary This strategic role is responsible for international regulatory policy and intelligence in the MEA and Eurasia Region (EAEU, Ukraine, Moldova, Georgia). The Director works closely with Senior Area Regulatory Directors, Regional and Global functions, and the International Regulatory Policy and Intelligence Team to develop impactful regulatory policy, advocacy and intelligence across the region and key international topics. The Director drives the development of regulatory policy positions, leads regulatory intelligence and legislation surveillance, translates developments into strategic insights, and ensures medicines reach patients across the region. Responsibilities include maintaining health authority relationships, influencing regulatory changes, leading implementation of strategy updates, communicating impacts to Global Project Teams, and developing advocacy plans with measurable KPIs.

What You'll Do
Lead and manage regulatory policy priority topics coordinated by the Global Regulatory Policy Team and International Policy and Intelligence Lead. Provide key regulatory procedural and environmental advice to internal stakeholders across Regulatory, Commercial, R&D, Operations, and CMO functions. Support preparation of regulatory policy documents, including position statements, reports, draft papers, and presentation materials. Oversee and manage the scorecard KPIs for international policy and intelligence performance. Support the development of the International Regulatory Policy Training Capability Framework within MEA and Eurasia. Establish the International CMC‐RA Policy Framework in collaboration with International CMCRA. Represent AZ International Regulatory Affairs on selected external trade association committees with a focus on MEA and Eurasia. Attend relevant external meetings and conferences, obtain intelligence, and communicate insights effectively. Represent AZ in external benchmarking on advocacy business practices. Create a culture of courageous leadership, creativity and collaboration. Contribute to the strategic direction and efficient operation of the immediate team and function. Essential for the Role 10+ years in global regulatory affairs, including experience in international regions such as Asia, Latin America, and Middle East & Africa. Understanding of the role of external policy and advocacy and its connection to business goals in International Regions. Demonstrated expertise in regulatory policy through Health Authority or Industry experience, with experience in at least two international regions. Working knowledge of AZ‐focused disease areas, new therapeutic modalities, CMC & quality, and cross‐area topics. Thorough understanding and application of the Drug Development and associated regulatory processes globally, including phase 3 design and end‐of‐phase 2 health authority interactions; experience leading response teams and labeling negotiations is a plus. Experience developing and executing new product strategies for global and international regions across therapeutic areas. A collaborative entrepreneurial mindset comfortable with ambiguity and adept at building from the ground up. Demonstrated proficiency in critical thinking, influencing, innovation, initiative, leadership, and excellent oral and written communication skills. Ability to think strategically and critically, evaluating risks to regulatory activities. Collaborative and able to build consensus with peers and leadership (influence upwards). Experience in knowledge management and digital information management. Desirable for the Role Experience working in a Health Authority. Problem‐solving skills. Focus on delivery and results. Experience with new modalities such as antibody‐conjugates, cell and gene therapy, radiotherapeutics. Participation in key industry groups and policy, especially within MEA and Eurasia. Excellent strategic influencing and negotiation skills. Degree in a scientific discipline such as pharmacy or biological science. Experience or aptitude in using AI/Gen AI within regulatory space. Why AstraZeneca At AstraZeneca we are dedicated to being a Great Place to Work, empowering you to push the boundaries of science and unleash your entrepreneurial spirit. Join an inclusive culture that champions diversity, collaboration, lifelong learning, growth and development, and pioneers the future of healthcare. Additional Information Date Posted: 20-Apr-2026Closing Date: 02-May-2026 AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team