Associate Regulatory Affairs Director I

Job Description

Job Title: Associate Regulatory Affairs Director I Global Career Level: E Introduction to role Are you ready to be part of a team that turns drug development strategies into reality? As an Associate Regulatory Affairs Director I, you will lead the planning, coordination, and execution of regulatory deliverables. This role requires a dynamic individual who can navigate various responsibilities, from regulatory project management to dossier management, ensuring our innovative medicines reach patients efficiently. Are you prepared to challenge the status quo and drive the right approvals for AstraZenecas expanding pipeline? Accountabilities In this role, you will be a key contributor to regulatory submission strategy, identifying risks and opportunities while leading applications through approval. You will provide expertise and guidance on procedural and documentation requirements, collaborating with cross-functional teams to achieve business objectives. Your responsibilities will include managing regulatory publishing deliverables, maintaining submission plans, and ensuring compliance with health authorities. You will also mentor junior staff, contribute to process improvement, and potentially lead teams or market-specific projects. Essential Skills/Experience Relevant University Degree in Science or related discipline Minimum 10 years regulatory experience within the biopharmaceutical industry, including license maintenance, labelling and publishing and of working across a range of markets, including regulated markets General knowledge of drug development Thorough knowledge of the regulatory product maintenance process Strong project management skills Leadership skills, including experience leading multi-disciplinary project teams Managed complex regulatory deliverables across projects/products Experience of working with people from locations outside of India, especially Europe and/or USA Desirable Skills/Experience Excellent English written and verbal communication skills Cultural awareness Scientific knowledge sufficient to understand regulatory issues and facilitate scientific discussions Proficiency with common project management (e.g., MS Project) and document management tools Ability to work independently and as part of a team Influencing and stakeholder management skills Ability to analyze problems and recommend actions Continuous Improvement and knowledge sharing focused At AstraZeneca, innovation is at our heart. We are committed to turning life-changing science into medicines that make a difference for patients worldwide. Our collaborative environment empowers you to ask questions, try new things, and lead breakthroughs. With a focus on technology adoption and automation, we strive for efficiencies that drive new innovations. Join us in our mission to bring life-changing medicines to patients and be part of a diverse team that values your unique contributions. Ready to make an impact? Apply now and be part of our journey to push beyond traditional boundaries in Regulatory Affairs! Date Posted 02-Jun-2025 Closing Date 08-Jun-2025