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Job ID R-228473 Date posted 06/11/2025 Job Title: Regulatory Dossier Manager Introduction to role: Are you ready to make a difference in the world of regulatory affairs? As a Regulatory Dossier Manager, you'll play a pivotal role within the Regulatory Technology & Operational Excellence framework, supporting our global regulatory partners. Your mission is to assist in planning and coordinating major submissions worldwide, facilitating collaboration with publisher vendors, and navigating the operational landscape to ensure seamless submission projects to regional partners and Health Authorities. Accountabilities: Assist regulatory project teams to ensure efficient delivery of submission outputs and compliance with submission deliverables. Provide assistance to Submission Delivery Teams or regional Regulatory Affairs Managers (RAM), across therapeutic areas. Aid in defining and agreeing on cross-functional delivery plans and lead times. Support coordination of cross-functional deliverables and RTE publishing resources, including outsourcing partnerships. Gain understanding of partner Service Level Agreements (SLA) and service offerings. Monitor the execution of RTE delivery, addressing issues under guidance. Develop a thorough understanding of submission delivery across global markets, contributing to strategic planning and operational efficiency. Actively seek to understand and stay informed about regulatory requirements and updates from Health Authorities around the world. Incorporate this knowledge into submission strategies and practices. Foster strong relationships with internal teams, external customers, and partners. Contribute to the development of the Global Content Plan (GCP) for Market Applications and Line Extensions. Support Clinical and Safety contributions to the GCP/SCP. Support the Regulatory Dossier Lead (RDL) with complex submission activities. Essential Skills/Experience: Bachelor’s degree (BA/BS) in Regulatory Affairs or a related scientific/technical field. At least 2-3 years of experience in the pharmaceutical/medical industry. Strong analytical and critical thinking skills, with excellent communication abilities. In-depth and extensive knowledge of the pharmaceutical drug development process. Exposure to global cross-functional project teams. Experience in one or more areas of Regulatory Affairs in the pharmaceutical or related industry. Familiarity with regulatory document or submission publishing, including various formats and market requirements. Desirable Skills/Experience: Experience in supporting submission publishing activities. Understanding of Regulatory Life Cycle Management. Good knowledge of eCTD Publishing. Good knowledge with Veeva systems. 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, we are driven by a vision to eliminate cancer as a cause of death. Our team is dedicated to pioneering new frontiers in oncology research, fusing cutting-edge science with the latest technology to achieve breakthroughs. With multiple indications and high-quality molecules at all stages of our innovative pipeline, we are committed to delivering impactful results. Empowered at every level, our collaborative research community works seamlessly with academia and industry partners to expedite research in some of the hardest-to-treat cancers. Join us and be part of a team that makes bold decisions driven by patient outcomes. Ready to take on this exciting challenge? Apply now and become part of our journey! 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. Regulatory Dossier Manager Posted date Jun. 11, 2025 Contract type Full time Job ID R-228473 APPLY NOW Why choose AstraZeneca India? Help push the boundaries of science to deliver life-changing medicines to patients. After 45 years in India, we’re continuing to secure a future where everyone can access affordable, sustainable, innovative healthcare. The part you play in our business will be challenging, yet rewarding, requiring you to use your resilient, collaborative and diplomatic skillsets to make connections. The majority of your work will be field based, and will require you to be highly-organised, planning your monthly schedule, attending meetings and calls, as well as writing up reports. Who do we look for? Calling all tech innovators, ownership takers, challenge seekers and proactive collaborators. At AstraZeneca, breakthroughs born in the lab become transformative medicine for the world's most complex diseases. We empower people like you to push the boundaries of science, challenge convention, and unleash your entrepreneurial spirit. You'll embrace differences and take bold actions to drive the change needed to meet global healthcare and sustainability challenges. Here, diverse minds and bold disruptors can meaningfully impact the future of healthcare using cutting-edge technology. Whether you join us in Bengaluru or Chennai, you can make a tangible impact within a global biopharmaceutical company that invests in your future. Join a talented global team that's powering AstraZeneca to better serve patients every day. Success Profile Ready to make an impact in your career? If you're passionate, growth-orientated and a true team player, we'll help you succeed. Here are some of the skills and capabilities we look for. 0% Tech innovators Make a greater impact through our digitally enabled enterprise. Use your skills in data and technology to transform and optimise our operations, helping us deliver meaningful work that changes lives. 0% Ownership takers If you're a self-aware self-starter who craves autonomy, AstraZeneca provides the perfect environment to take ownership and grow. Here, you'll feel empowered to lead and reach excellence at every level — with unrivalled support when you need it. 0% Challenge seekers Adapting and advancing our progress means constantly challenging the status quo. In this dynamic environment where everything we do has urgency and focus, you'll have the ability to show up, speak up and confidently take smart risks. 0% Proactive collaborators Your unique perspectives make our ambitions and capabilities possible. Our culture of sharing ideas, learning and improving together helps us consistently set the bar higher. As a proactive collaborator, you'll seek out ways to bring people together to achieve their best. Responsibilities Job ID R-228473 Date posted 06/11/2025 Job Title: Regulatory Dossier Manager Introduction to role: Are you ready to make a difference in the world of regulatory affairs? As a Regulatory Dossier Manager, you'll play a pivotal role within the Regulatory Technology & Operational Excellence framework, supporting our global regulatory partners. Your mission is to assist in planning and coordinating major submissions worldwide, facilitating collaboration with publisher vendors, and navigating the operational landscape to ensure seamless submission projects to regional partners and Health Authorities. Accountabilities: Assist regulatory project teams to ensure efficient delivery of submission outputs and compliance with submission deliverables. Provide assistance to Submission Delivery Teams or regional Regulatory Affairs Managers (RAM), across therapeutic areas. Aid in defining and agreeing on cross-functional delivery plans and lead times. Support coordination of cross-functional deliverables and RTE publishing resources, including outsourcing partnerships. Gain understanding of partner Service Level Agreements (SLA) and service offerings. Monitor the execution of RTE delivery, addressing issues under guidance. Develop a thorough understanding of submission delivery across global markets, contributing to strategic planning and operational efficiency. Actively seek to understand and stay informed about regulatory requirements and updates from Health Authorities around the world. Incorporate this knowledge into submission strategies and practices. Foster strong relationships with internal teams, external customers, and partners. Contribute to the development of the Global Content Plan (GCP) for Market Applications and Line Extensions. Support Clinical and Safety contributions to the GCP/SCP. Support the Regulatory Dossier Lead (RDL) with complex submission activities. Essential Skills/Experience: Bachelor’s degree (BA/BS) in Regulatory Affairs or a related scientific/technical field. At least 2-3 years of experience in the pharmaceutical/medical industry. Strong analytical and critical thinking skills, with excellent communication abilities. In-depth and extensive knowledge of the pharmaceutical drug development process. Exposure to global cross-functional project teams. Experience in one or more areas of Regulatory Affairs in the pharmaceutical or related industry. Familiarity with regulatory document or submission publishing, including various formats and market requirements. Desirable Skills/Experience: Experience in supporting submission publishing activities. Understanding of Regulatory Life Cycle Management. Good knowledge of eCTD Publishing. Good knowledge with Veeva systems. 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, we are driven by a vision to eliminate cancer as a cause of death. Our team is dedicated to pioneering new frontiers in oncology research, fusing cutting-edge science with the latest technology to achieve breakthroughs. With multiple indications and high-quality molecules at all stages of our innovative pipeline, we are committed to delivering impactful results. Empowered at every level, our collaborative research community works seamlessly with academia and industry partners to expedite research in some of the hardest-to-treat cancers. Join us and be part of a team that makes bold decisions driven by patient outcomes. Ready to take on this exciting challenge? Apply now and become part of our journey! 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. APPLY NOW Explore the local area Take a look at the map to see what’s nearby. Reasons to Join Thomas Mathisen Sales Representative Oslo, Norway Christine Recchio Sales Representative California, United States Stephanie Ling Sales Representative Petaling Jaya, Malaysia What we offer We're driven by our shared values of serving people, society and the planet. Our people make this possible, which is why we prioritise diversity, safety, empowerment and collaboration. Discover what a career at AstraZeneca could mean for you. Lifelong learning Our development opportunities are second to none. You'll have the chance to grow your abilities, skills and knowledge constantly as you accelerate your career. From leadership projects and constructive coaching to overseas talent exchanges and global collaboration programmes, you'll never stand still. Autonomy and reward Experience the power of shaping your career how you want to. We are a high-performing learning organisation with autonomy over how we learn. Make big decisions, learn from your mistakes and continue growing — with performance-based rewards as part of the package. Health and wellbeing An energised work environment is only possible when our people have a healthy work-life balance and are supported for their individual needs. That's why we have a dedicated team to ensure your physical, financial and psychological wellbeing is a top priority. Inclusion and diversity Diversity and inclusion are embedded in everything we do. We're at our best and most creative when drawing on our different views, experiences and strengths. That's why we're committed to creating a workplace where everyone can thrive in a culture of respect, collaboration and innovation.
