Manager RIM (Regulatory Information Management) AstraZeneca India

About AstraZeneca India

Job Description

The Manager, Regulatory Information is responsible for supporting the management, collection, creation, and analysis of regulatory data and regulatory information. You will act as an expert in end-to-end Regulatory Information Management, focusing on dossier format, publishing, and tracking. In this role, you will represent and manage the interface between Global Regulatory Operations (GRO) delivery units and early as well as late-stage drug projects. Collaborating with GRO teams and partners, you will ensure efficient delivery of end-to-end Regulatory Information Management. Your key accountabilities will include managing and governing regulatory data for assigned areas in alignment with regulatory data standards, business processes, and regulatory requirements. You will compile and deliver XEVMPD, IDMP, or other regulatory data submissions to health authorities. Developing expertise in critical topic areas related to the RIM remit, especially technical skills and knowledge of international regulations, is essential. Engaging with partners, affiliates, and other stakeholders will be crucial to managing regulatory data and ensuring compliance with procedures and standards. Additionally, you will monitor changes in legislation related to regulatory information and evaluate regulations, guidelines, and technical specifications. The ideal candidate should hold a university degree in life sciences or possess equivalent experience in the pharmaceutical/medical industry. Strong analytical and critical thinking abilities are required, along with a good understanding of current regulatory legislation, guidelines, and trends pertaining to regulatory information processes, tools, and standards. Desired skills and experience include problem-solving and conflict resolution skills, the ability to set and manage priorities, performance targets, and project initiatives. Innovation in best practices through business process analysis and design is valued, as well as the ability to thrive in a fast-paced environment. At AstraZeneca, we encourage unexpected teams to come together, fostering bold thinking that can inspire life-changing medicines. While we have a minimum requirement of three days per week in the office to facilitate connections, collaboration, and rapid work, we also respect individual flexibility. We offer a supportive environment that nurtures both your professional and personal growth, with defined career progression, a recognition culture for celebrating successes, and exciting opportunities for those who are driven to excel. If you are ready to make a difference, we invite you to apply now and join us in our unique and ambitious world.,