Roles & Responsibilities
• Lead regulatory affairs for assigned franchise(s) from clinical development through lifecycle management
• Develop and implement regulatory strategies, including risk mitigation and accelerated approval pathways
• Drive SEC preparedness and support India’s inclusion in global clinical trials
• Ensure 100% regulatory compliance, including post-approval commitments, labeling, site transfers, and biologics
• Act as GRP Lead and ensure adherence to Good Regulatory Practices and quality management systems
• Lead internal and external audits, ensuring deviations and CAPAs are addressed effectively
• Collaborate cross-functionally with business, medical, QA, supply, and global regulatory teams
• Support regulatory policy shaping, health authority advocacy, and industry association initiatives
• Provide regulatory support to business development projects and oversee regulatory intelligence
• Manage and develop regulatory team members (direct and indirect reports)
Qualifications
• Bachelor’s degree in Pharmacy (mandatory)
• Post-graduate qualification in Pharmacy (preferred)
Experience
• Proven experience in regulatory affairs, drug development, and clinical trials
• Prior people management and team leadership experience
• Experience with innovative treatment modalities (desirable)
Skills
• Strong knowledge of Indian regulatory requirements
• Strategic regulatory planning and risk management
• Effective stakeholder management and cross-functional collaboration
• Strong communication, leadership, and decision-making skills
About the Organisation
AstraZeneca is a global, science-led biopharmaceutical company focused on the discovery, development, and commercialization of innovative medicines. With a strong commitment to patient safety, scientific excellence, and ethical practices, AstraZeneca fosters an inclusive culture that encourages continuous learning, collaboration, and growth while advancing the future of healthcare worldwide.
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