International Regulatory Affairs Manager I

Job Title International Regulatory Affairs Manager I Global Career Level D1 Introduction to role Within International Regulatory Affairs we take innovative regulatory approaches to bring life-changing medicines to patients in international markets We work across the AstraZeneca pipeline and business to accelerate regulatory approvals for new medicines in international markets as efficiently and effectively as possible so that no patient waits A fantastic permanent opportunity has now arisen for a Regulatory Affairs Manager I to join our International Regulatory Affairs Management iRAM team The Regulatory Affairs Manager I 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 I in International Regulatory Affairs will be responsible for the tactical delivery of international submissions including Marketing Authorisation Applications MAAs Clinical Line Extensions CLEs and Life Cycle Maintenance LCM within an assigned International Regulatory Team IRT The Regulatory Affairs Manager I is expected to work flexibly to deliver these varied accountabilities as assigned by their line manager or the International Regulatory Affairs Manager Lead iRAM Lead for their allocated projects The Regulatory Affairs Manager I is fully proficient in applying established standards and performs regulatory affairs management for moderately to highly complex international market submissions in all regions with minimal coaching They are expected to facilitate strategic input provide proactive contribution to submission planning identify areas for continuous improvement and lead cross-functional activities They participate in the continuous improvement of processes and tools systems Accountabilities - Understands the regulatory framework including regional or International Market 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 - Tactical delivery for international submission dossiers for MAA CLE and LCM applications in all international markets - Coordination review and authoring contribution to HAQ responses and other associated regulatory maintenance documents - Analysis of regulatory procedures pathways and special designations used during development authorizations and extension of the product especially in International space - Uses and shares best practices when handling various applications and procedures during interactions with health authorities and in day-to-day work - Leads and or contributes to the planning preparation including authoring where relevant and delivery of complex regulatory maintenance submissions from an international market perspective - Liaises closely with cross-functional members with aligned product responsibilities - Develops executes and maintains submission delivery plans submission content plans and proactively provides status updates to designated stakeholders - Coordinates the input maintenance and revision in the project planning tools for assigned projects and highlights unforeseen changes in resource demand in a timely manner to iRAM Lead and Line Manager - Identifies regulatory risks and proposes mitigations to iRAM Lead IRT meetings and as necessary with cross-functional teams - Supports operational and compliance activities for assigned deliverables including generating submission content plans submission tracking and document management - High efficiency in Regulatory Intelligence Power BI Spotfire reports and Veeva RIMS management for day-to-day RAM activities - Provides coaching mentoring and knowledge sharing within the international regulatory organization - Actively seeks continuous improvement opportunities Essential Skills Experience - Relevant University Degree in Science or related discipline - Minimum 6 years of relevant regulatory experience within the biopharmaceutical industry focusing on international markets including new MAAs license maintenance and labeling - General knowledge of drug development - Good knowledge of the regulatory New MAA roll-out and product maintenance process - Strong project management skills - Knowledge of international markets in some or all international regions Desirable Skills Experience - Regulatory affairs experience across a broad range of international markets - Experience in Veeva Regulatory Information Management system RIM report generation in applicable tools Power BI or Regulatory Intel systems - Experience working with people from locations outside of India especially in the international regions - 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 When we put unexpected teams in the same room we unleash bold thinking with the power to inspire life-changing medicines In-person working gives us the platform we need to connect work at pace and challenge perceptions That s why we work on average a minimum of three days per week from the office But that doesn t mean we re not flexible We balance the expectation of being in the office while respecting individual flexibility Join us in our unique and ambitious world At AstraZeneca innovation is at our heart We empower our teams to think broadly about patients needs and what it takes to prevent and treat diseases Our collaborative environment encourages creative thinking allowing us to lead breakthroughs that shape drug development strategies With a commitment to continuous improvement we strive to deliver rapid global approvals that bring new medicines to patients Join us in our mission to make a meaningful impact on healthcare Ready to make a difference Apply now to join our team Date Posted 17-Sept-2025 Closing Date 23-Sept-2025 AstraZeneca embraces diversity and equality of opportunity We are committed to building an inclusive and diverse team representing all backgrounds with as wide a range of perspectives as possible and harnessing industry-leading skills We believe that the more inclusive we are the better our work will be We welcome and consider applications to join our team from all qualified candidates regardless of their characteristics We comply with all applicable laws and regulations on non-discrimination in employment and recruitment as well as work authorization and employment eligibility verification requirements