Regulatory Affairs Intelligence Sr Mgr

Key Responsibilities:

• Contribute to the monitoring, analysis, and reporting of global regulatory developments to support timely and compliant product submissions.
• Deliver high-quality regulatory intelligence outputs such as summaries of country-specific requirements, impact assessments, and recommendations on filing strategies.
• Oversee regulatory intelligence tools, databases, and processes to ensure effective monitoring, analysis, and communication.
• Maintain and improve regulatory monitoring systems and evaluate automation or outsourcing opportunities to enhance operational efficiency.
• Analyze global regulatory trends to identify cross-market submission requirements and provide strategic input for globally aligned dossier content and filing approaches.
• Anticipate and help manage major impending regulatory changes by supporting business readiness initiatives and contributing to enterprise regulatory change managemen...