Angitia Biopharmaceuticals

Compliance

• Lead the development and execution of global regulatory strategies for assigned development programs
• Lead the product's Global Regulatory Team and represent Regulatory Affairs on governance and cross-functional development teams
• Provide regulatory leadership across nonclinical, clinical, CMC, registration, and lifecycle management activities
• Partner with cross-functional teams to shape development plans, study designs, endpoints, and regulatory pathways
• Identify regulatory risks and opportunities and develop mitigation and management recommendations
• Lead regulatory strategy and execution for health authority interactions, including meeting preparation, briefing materials, and responses
• Provide strategic oversight and direction of major regulatory submissions, including INDs, CTAs, amendments, and marketing applications
• Direct global and regional submission strategies with regional regulatory stakeholders
• Ensure regulatory submissions are scientifically sound, strategically aligned, and high quality
• Monitor evolving regulatory requirements and assess their impact on development programs
• Build and maintain relationships with regulatory authorities, consultants, contractors, and partners
• Influence cross-functional teams to achieve program objectives while balancing regulatory and business considerations
• Mentor junior regulatory professionals and contribute to departmental initiatives, process improvements, and capability development
• Provide regulatory recommendations and strategic input to senior management and governance committees
• Maintain a global perspective and promote alignment across programs, regions, and functional areas

Explore Director, Global Regulatory Affairs at Angitia Biopharmaceuticals. Review requirements and application details.