Regulatory Affairs Lead Astrazeneca Pharma India Ltd.

ROLE SUMMARY

The Regulatory Affairs Lead is responsible for driving regulatory strategies and managing submissions across the product lifecycle to ensure compliance with local and global requirements. The role provides expert advice on processes and documentation, proactively manages regulatory risks, and partners with health authorities and internal stakeholders to enable timely patient access to innovative medicines.

What you ll do

Regulatory Strategy & Submissions

• Lead submission management and cross-functional teams for complex global regulatory applications, ensuring compliance with AstraZeneca s submission-ready standards.
• Provide regulatory expertise and strategic input to product and project teams, anticipating Health Authority requirements and guiding submissions-related activities.
• Identify potential regulatory risks to global and regional operational plans, proposing mitigation strategies.
• Implement and oversee strategies that improve the quality, efficiency, and timeliness of submissions.
• Manage processes related to product licenses, registrations, and post-marketing requirements, including labeling, safety reporting, inspections, and audits.
• Act as the primary regulatory contact with key authorities (e.g., SFDA, GHC) and ensure timely updates to global systems on regulatory guidelines, decrees, and communications.

Business Partnering & Country RA Agenda

• Serve as the regulatory contact for the Country Head and Business Unit Directors (BUDs).
• Conduct regular meetings with local agents regulatory teams to align on outstanding activities and ensure smooth execution.
• Foster alignment across therapy area RA managers, local agents, and global stakeholders on regulatory priorities.
• Represent AstraZeneca s regulatory interests in official engagements with authorities and industry forums.

Leadership & People Development

• Manage and develop a small team of regulatory professionals (1 2 direct reports), setting clear objectives, coaching, and providing growth opportunities.
• Promote a culture of collaboration, creativity, and courageous leadership across teams.
• Lead or participate in critical projects, ensuring regulatory business needs are integrated into AZ s systems, processes, and standards.

External Engagement & Business Awareness

• Build and maintain strong relationships with Regulatory Health Authorities, industry representatives, and key external partners.
• Monitor regulatory, policy, and industry dynamics, proactively advising internal stakeholders on potential impacts.
• Support business development activities, including proposals, reports, costing, and budgets, ensuring alignment with corporate strategy.

Governance & Compliance

• Ensure all regulatory activities adhere to AstraZeneca s Code of Ethics, corporate policies, and local legislation.
• Timely reporting of adverse events, compliance risks, conflicts of interest, and health/environment-related incidents.
• Provide regulatory input for audits, inspections, recalls, and related communications to minimize compliance risks.