Kailera Therapeutics

Compliance

• Serve as the regulatory representative on core teams
• Develop and plan regulatory submission strategies
• Coordinate preparation of submissions to regulatory agencies
• Conduct regulatory intelligence activities
• Oversee compilation, review, and submission of regulatory applications and submissions, ensuring accuracy, completeness, and timeliness
• Monitor the regulatory environment and communicate developments to clinical, regulatory, senior leadership, and other stakeholders
• Stay updated on global regulatory guidance and regulations
• Communicate key regulatory updates to senior leadership and project team management
• Ensure compliance with reporting requirements, including annual and periodic reports
• Respond to regulatory questions from authorities in collaboration with clinical development, safety, and other subject matter experts
• Provide strategic regulatory guidance for global development and registration programs, including INDs, CTAs, NDAs, and MAAs
• Assess and communicate regulatory requirements
• Contribute to processes and procedures, including authoring internal work instructions and company SOPs

Associate Director, Global Regulatory Affairs

• Lead the development, review, and maintenance of U.S. prescribing information, patient labeling, Medication Guides, Instructions for Use, primary and secondary carton labeling, and promotional labeling
• Provide regulatory guidance on product labeling throughout development, registration, launch, and post-approval lifecycle management
• Collaborate with clinical, CMC, medical, safety, device engineering, technical operations, and commercial teams
• Support labeling negotiations with the FDA and manage implementation of approved labeling updates
• Evaluate proposed safety, efficacy, and scientific claims for consistency with approved labeling
• Serve as a core member of the Medical, Legal, Regulatory review process and collaborate with the MLR process owner
• Ensure compliance with FD&C Act requirements, FDA advertising and promotion regulations, OPDP guidance and enforcement trends, PhRMA Code requirements, and company policies and procedures
• Provide regulatory recommendations for compliant and effective non-promotional and promotional communications
• Monitor evolving FDA guidance, enforcement actions, warning letters, and industry best practices
• Contribute to SOPs, policies, and governance processes

Associate Director, Global Regulatory Affairs

Associate Director, Global Regulatory Labeling, Ad Promo