Lead Regulatory Affairs

Role & Responsibilities
• Lead regulatory affairs for assigned franchise from clinical development to lifecycle maintenance
• Prepare regulatory strategies including risk mitigation plans for accelerated approvals of new products and clinical trials
• Drive SEC preparedness along with medical teams
• Ensure ~100% regulatory compliance, including post-approval commitments, labelling, site transfers, and biologicals
• In-depth knowledge of Indian regulations and regulatory expertise in innovative treatment modalities
• Collaborate cross-functionally with business, QA, medical, and supply teams, as well as with International Regulatory Affairs to ensure alignment
• Act as GRP lead and perform periodic reviews of RA functions as per GRP Quality Management Systems
• Lead internal/external audits for RA-relevant areas, ensuring deviations and CAPAs are in place
• Contribute to regulatory policy shaping and advocacy efforts through industry associations
• Ensure the training of the regulatory team on new and updated procedures
• Provide regulatory support for Business Development projects and oversee regulatory intelligence
• Manage a team of 3–4 people, providing development and monitoring initiatives as needed

Qualification
• Pharmacy graduate (essential)
• Post-graduate qualification in Pharmacy (desirable)

Experience
• People management experience
• Experience in regulatory affairs, drug development, clinical trials (preferred)
• Regulatory expertise in newer treatment modalities

Skills
• Strong knowledge of global/local clinical trials and regulatory strategy
• Ability to lead teams and manage cross-functional collaborations
• Experience with regulatory compliance, audits, and post-approval processes

About the Company
AstraZeneca is a global, science-led, patient-focused biopharmaceutical company dedicated to the discovery, development, and commercialization of prescription medicines. AstraZeneca’s work is driven by an entrepreneurial spirit and a commitment to innovation. With a culture of inclusivity and diversity, AstraZeneca continues to push the boundaries of science to improve lives across the globe.