Regulatory Affairs Manager I

Job Description 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.