Regulatory Affairs Manager II

JOB TITLE: REGULATORY AFFAIRS MANAGER II CAREER LEVEL: D Role Type: Individual Contributor for Global Markets ABOUT ASTRAZENECA AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies. At AstraZeneca, we 're dedicated to being a Great Place to Work. ABOUT THE ROLE Description: The Regulatory Affairs Manager II is a regulatory specialist with project management capabilities responsible for leading the end-to-end planning, coordination, and execution of assigned global deliverables in the maintenance Center of Excellence, as an individual contributor. The Regulatory Affairs Manager II may have to take on the accountabilities for a number of different roles within a Global Regulatory Execution Team (GRET). The Regulatory Affairs Manager II is expected to be able to work flexibly to deliver these varied accountabilities as assigned to them by their Portfolio director. The Regulatory Affairs Manager II is fully proficient in applying established standards to perform regulatory affairs management for moderately complex products/regions and under minimal supervision. Capable of leading cross functional activities. Participates in 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 to GRET and cross-functional teams working flexibly within and across regions to ensure the delivery of business objectives. Provides regulatory labeling expertise and leads the maintenance of global labeling documents for Established brands. Is responsible for the regulatory activities involved in the coordination, development and implementation of revised printed labeling for allocated products, including USPIs and other regional labeling. 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 of all dossiers including established brands and all application types per market and /or region including Divestments, Marketing authorization transfer (MAT) and withdrawals. Provide scientific contribution to single documents such as PSRs, response documents, , regulatory maintenance documents Risk Management Plans, , Addendum to Clinical and NonClinical Overview, Pharmacovigilance agreement (PVA), Core labelling documentation (e.g. Company Core Data Sheets, USPI, EUQRD and Core Safety Profiles), etc. Analysis of regulatory procedures and special designations used during development, authorization and extension of the product. Uses and shares best practices when handling various applications and procedures during interactions with health authorities and in day-to-day work, while operating in a highly dynamic environment. Leads and / or contributes to the planning, preparation (including authoring where relevant) and delivery of simple, and with experience, increasingly more complex regulatory maintenance submissions Liaise closely with cross-functional members with aligned product responsibilities. Develops, executes and maintains submission delivery plans, submission content plans using digital tools like Veeva Vault (ERV) and compliance, and proactively provides status updates to designated stakeholders. Coordinates the input, maintenance and revision in the project planning tools for assigned projects and highlight unforeseen changes in resource demand in a timely manner to Lead RPM and line manager. Identifies regulatory risks and proposes mitigations to Lead RPM and cross functional teams. Supports operational and compliance activities for assigned results, including generating work requests and submission content plans, submission tracking, TMF, and document management applying the support and input of Global Regulatory Operations, Marketing Companies, CROs and/or alliance partners where relevant. Provides coaching, mentoring and knowledge sharing within the regulatory organization. Contributes to process improvement. Use available AI tools effectively and responsibly to improve efficiency, streamline routine activities, and support high-quality regulatory deliverables Minimum Requirements –Education and Experience Relevant University Degree in Science or related discipline Minimum 8&#43; years of relevant Regulatory experience within the biopharmaceutical industry, including license maintenance, labelling and publishing, and of working in 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. Preferred Experience The US Regulatory affairs experience Managed regulatory deliverables at the project level Experience of working with people from locations outside of India, especially Europe and/or USA Skills and Capabilities · 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 · Basic understanding of emerging technologies like AI, ML etc · Demonstrate ability to use digital tools and solutions relevant to own work tasks to support productivity, collaboration and learning · Work proactively to understand future needs and opportunities for digital transformation that improve the effectiveness and speed of core business processes and decision making. · 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 Internal and External Contacts/Customers Global Regulatory Leads (GRLs) Regulatory Regional Leads (eg, US, EU, International RADs) Lead RPM Other R & D skill groups, eg, Clinical, Clinical Operations, GRO, Labeling, Reg CMC, Operations regulatory, Patient Safety, Regulatory Central, GRL, Regional Leads. Operations/Manufacturing organization (CMC post approval) Marketing Companies/Local affiliates Health Authorities External collaboration partners Reporting Relationship <s