VP Regulatory Affairs

Requirements

• Lead the development and execution of global regulatory strategies to support development programs and market applications.
• Ensure effective implementation of regulatory strategies.
• Manage the Regulatory team in developing submissions and collaborating across functions.
• Oversee planning and execution of submissions, ensuring timely and high quality documentation.
• Interpret and communicate data effectively within cross-functional teams and with regulatory authorities.
• Incorporate corporate planning and other factors into regulatory strategies, maintaining alignment with global health authority requirements.
• Prepare risk assessments on regulatory topics, predicting potential issues and developing contingency plans.
• Build and maintain strong relationships with internal and external stakeholders.
• Ensure dossiers comply with ICH and local requirements across various countries.