Regulatory Affair Manager

Responsibilities

• ● Regulatory Affairs Manager - Mumbai
• ● About AstraZeneca
• ● AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that concentrates on the discovery, development and commercialization of prescription medicines addressing some of the planet's most serious diseases. But we're more than one of the world's leading pharmaceutical companies.
• ● Accountabilities:
• ● Lead or participate as an expert regulatory member of cross-functional teams to provide strategic advice and operational support throughout the regulatory process, including product development, registration, launch, lifecycle management, and post-marketing activities.
• ● Plan, manage, and deliver complex global and/or regional regulatory submissions, briefing materials, responses to health authorities, and required documentation for all types of applications and maintenance activities.
• ● Advise senior management, product development teams, and business partners on regulatory strategies, project risks, timelines, and compliance requirements, ensuring that all commitments are clearly communicated and met.
• ● Drive continuous improvement in submission preparation and delivery processes, including electronic and paper publishing, documentation quality, and compliance with both local and global regulatory standards and AZ policies.
• ● Identify complex regulatory risks, propose and implement mitigation strategies, and ensure operational and strategic challenges are efficiently addressed.
• ● Build and maintains effective partnerships and communication channels with internal partners across functions (including Regulatory, R&D, Operations, Marketing, Manufacturing) as well as external partners such as health authorities, industry consortia, and vendors.
• ● Ensure that department systems and records accurately reflect regulatory statuses and submissions, promoting strong compliance with internal standards and external regulatory expectations.
• ● Coach and mentor colleagues, share regulatory expertise, and help develop the skills and capabilities within the team to cultivate a culture of courageous leadership, collaboration, and high performance.
• ● Keep abreast of changing worldwide health authority requirements, interpret and communicate regulatory intelligence, and drive the adoption of new requirements and standards into business processes.
• ● Champion the development and implementation of new regulatory systems, technologies, and strategies to strengthen AstraZeneca's regulatory operations and maintain industry leadership. Skills:
• ● Why AstraZeneca
• ● At AstraZeneca, we 're dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There's no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We're on an exciting journey to pioneer the future of healthcare.
• ● 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.
• ● Also You can find alternative messaging to use in the 'Global Talent Attraction Story messaging' section of the Global Playbook on the Employer Brand Portal - try to use other examples in order to make it different for candidates
• ● So, what's next
• ● Are you already imagining yourself joining our team Good, because we can't wait to hear from you.