Regulatory Affairs Lead

Role Summary

Regulatory Strategy and Submissions

• Lead submission management and cross-functional teams for complex global regulatory applications.
• Ensure submissions comply with AstraZeneca's submission-ready standards.
• Provide regulatory expertise and strategic input to product and project teams.
• Anticipate Health Authority requirements and guide submission-related activities.
• Identify regulatory risks to global and regional operational plans and propose mitigation strategies.
• Implement strategies to improve submission quality, efficiency, and timeliness.
• Manage product licenses, registrations, labeling, safety reporting, inspections, audits, and post-marketing requirements.
• Act as the primary regulatory contact with key authorities including SFDA and GHC.
• Ensure timely updates to global systems on regulatory guidelines, decrees, and communications.

Business Partnering and Country Agenda

• Partner with Business Units and internal stakeholders to support the country regulatory agenda under the Regulatory Affairs & Pricing Director.
• Conduct regular meetings with local agents' regulatory teams to align outstanding activities and ensure smooth execution.
• Foster alignment across therapy area regulatory affairs managers and local stakeholders.

Requirements

• Regulatory expertise in product lifecycle strategy, submissions, and compliance.
• Ability to manage complex global regulatory applications and submission-related activities.
• Ability to anticipate health authority requirements and provide strategic regulatory input.