International Regulatory Affairs Manager

Start free →

Or apply yourself on the official page →

About the role

JOB TITLE: Regulatory Affairs Manager II, International Regulatory Affairs Lead the way for a new breed of solutions-oriented Regulators Champion a new approach to Regulatory that supports quick decision-making and balanced risk-taking. Curious enterprise-thinkers we proactively take a strategic approach earlier in the product lifecycle to get involved in shaping drug development Be part of the team where you are empowered to follow the science Be part of the solution, turning our drug development strategies into reality. Work at all stages of development to translate our life-changing science into medicines to get the best results for AstraZeneca, patients in need and healthcare professionals.. About astrazeneca At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth and development About the team We are a diverse and open-minded team harnessing our different skills and experiences. As a Regulatory function we use our capabilities to accelerate discovery and development. Combining knowledge from across our Therapy Areas helps us to deliver rapid and global approvals that bring new medicines to patients. About the role Description: The Regulatory Affairs Manager II in International Regulatory Affairs is a regulatory specialist with project management capabilities responsible for leading the end-to-end planning, coordination, and execution of assigned deliverables, including delivery as an individual contributor. The Regulatory Affairs Manager II in International Regulatory Affairs will be responsible for tactical delivery of Int’l Marketing Authorisation Applications (MAAs) and Clinical Line Extensions (CLEs within an assigned Global Regulatory Execution Team (GRET). The Regulatory Affairs Manager II is expected to be able to work flexibly to deliver these accountabilities as assigned to them by their line manager or by the Lead Regulatory Project Manager (RPM) for their allocated GRET(s). The Regulatory Affairs Manager II is fully proficient in applying established standards. Performs Regulatory Affairs Management for highly complex International market submissions under minimal supervision. May facilitate strategic input, capable of leading cross functional activities. Capable of leading cross functional activities. Participates continuous improvement of process and tools/systems. Regulatory Affairs Management Contributes to regulatory submission strategy, identifying submission risks and opportunities, while leading simple through more complex regulatory applications and managing procedures through approval. Provides regulatory expertise and guidance on procedural and documentation requirements for International markets to GRET, Global Regulatory Strategy Team (GRST) and cross-functional teams working flexibly within and across regions to ensure the delivery of business objectives. Accountabilities/Responsibilities: Regulatory Affairs Management • Understands the regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions. • Provides regulatory input on procedural and documentation requirements as defined by Health Authorities for assigned deliverable(s) including: • Submission delivery strategy for MAA and CLE dossiers market and /or region. • Contribute to and review of response documents • Analysis of regulatory procedures and special designations used during development, authorizations and extension of the product. • Uses and shares

View the official posting →