Regulatory Affairs Manager I

Job Title Regulatory Affairs Manager I Global Career Level D1 Introduction to role Are you ready to be part of a team that transforms drug development strategies into reality 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 if required The Regulatory Affairs Manager I may take on the accountabilities for a number of different roles within a Global Regulatory Execution Team GRET Regulatory Affairs Management andGlobal Labelling Management The Regulatory Affairs Manager I is expected to be able to work flexibly to deliver these varied 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 I is fully proficient in applying established standards to perform regulatory affairs management for simple moderately complex products regions and under minimal supervision 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 to GRET Global Regulatory Strategy Team GRST and cross-functional teams working flexibly within and across regions to ensure the delivery of business objectives Global Labelling Management Provides regulatory labeling expertise and leads the maintenance of global labeling documents for allocated products Is responsible for the regulatory activities involved in the coordination development and implementation of revised printed labeling for allocated products including CDS USPI and EUQRD Accountabilities 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 US EU GB Japan China Canada Switzerland Israel Serbia Montenegro EUCAN Bosnia Herzegovina Kosovo Albania North Macedonia 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 study protocols regulatory maintenance documents Risk Management Plans Periodic Safety Update Reports 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 authorizations 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 submissions from either a global and or international markets like INDs CTAs EU PIP Briefing document scientific advice Investigational brochure IB Target product profile TPP MAAs NDAs CSRs CSP Liaises 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 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 deliverables including generating work requests and submission content plans submission tracking TMF and document management utilizing 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 organisation Contributes to process improvement Global Labelling Management This will include the maintenance of core labeling documents including the Core Data Sheet and Core Patient Information Leaflet including labelling history documents the maintenance and corporate approval of EU SmPC and US PI and packaging component labeling while ensuring consistency with applicable core labeling documents and internal standards and SOPs Ensuring that updates to the core texts are completed communicated to relevant stakeholders in a timely manner and impositons deviations are agreed and documented appropriately Essential Skills Experience Education and Experience Relevant University Degree in Science or related discipline Minimum 7 years of relevant Regulatory experience within the biopharmaceutical industry including license maintenance labelling and publishing and of working in regulated global markets General knowledge of drug development Thorough knowledge of the regulatory product maintenance process Strong project management skills and Leadership skills Skills and Capabilities Excellent English written and verbal communication skills Knowledge of Veeva vault for submission compilation publishing and approval processes standards systems and CTIS tools Proficiency with common project management e g MS Project and document management tools Basic understanding of emerging technologies like AI ML and use it proactively for digital transformation to improve the effectiveness and speed of core business processes and decision making Experience of working with people from locations outside of India especially Europe and or USA Flexible to work outside India time zone with the EU and US stakeholders as and when needed Ability to work independently and as part of a team to support productivity collaboration and learning Ability to analyze problems and recommend actions Influencing and stakeholder management skills Continuous Improvement and knowledge sharing focused Scientific knowledge sufficient to understand regulatory issues and facilitate scientific discussions Internal and External Contacts Customers Lead RPM and Global Regulatory Leads GRLs Regulatory Regional Leads eg US EU International RADs iRAM and iRAM lead RAAs Other R D skill groups eg Non clinical Clinical Clinical Operations Biometric EU QPPV CReW GLA iREACH GRO Labeling Reg CMC Operations regulatory Patient Safety Global regulatory intelligence Regulatory Technology GRL GPT team members Regulatory Business development Regional Leads Marketing Pricing team Device team Operations Manufacturing organisation etc Marketing Companies Local affiliates Legal Health Authorities External collaboration partners Reporting Relationship Direct Reports - None Indirect Reports -None 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 AstraZeneca offers an environment where innovation thrives Here you ll be part of a dynamic team that values curiosity and creativity Our approach to Regulatory is progressive focusing on solutions that drive efficiencies and new innovations With opportunities to work on projects at all stages of development you ll be empowered to make quick decisions and influence drug development strategy Your professional growth is supported through a defined career ladder and recognition culture that celebrates successes Ready to make a difference Apply now to join our team Date Posted 17-Oct-2025 Closing Date 26-Oct-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