Temporary Regulatory Affairs Specialist - Hanoi

Please apply using the link below: [protected info]
Job Summary: We are seeking a highly motivated Temporary Regulatory Affairs Specialist to support our team in ensuring the timely and compliant submission and maintenance of our products within a dynamic international regulatory landscape. This role is crucial for managing regulatory documentation and processes and contributing to our overall regulatory strategy.
Job Responsibilities:
• Manage and execute change control processes for regulatory submissions, ensuring compliance with global regulations.
• Communicate effectively with internal and external stakeholders, including health authorities and cross-functional teams, regarding regulatory matters.
• Contribute to the continuous monitoring of evolving regulatory requirements and guidelines, assessing their impact on company products and processes.
• Deliver results by successfully preparing, submitting, and maintaining regulatory dossiers and documentation within established timelines.
• Display resilience and adaptability in navigating complex regulatory challenges and evolving priorities.
• Oversee and ensure accurate document lifecycle management for all regulatory submissions and supporting documentation.
• Manage self effectively, demonstrating strong organizational skills and the ability to prioritize tasks independently.
• Apply project management principles to regulatory initiatives, ensuring projects are completed efficiently and effectively.
• Identify and mitigate project risk management pertaining to regulatory submissions and activities.
• Ensure strict adherence to regulatory compliance standards across all aspects of product development and commercialization.
• Navigate and contribute to the efficiency of the regulatory process, identifying areas for improvement.
• Support regulatory relationship management with health authorities and other external partners.
• Contribute to the development and implementation of regulatory strategy to support product development and market access.
• Think and solve problems proactively, identifying solutions to complex regulatory issues.
• Work collaboratively with cross-functional teams, including R&D, Quality, and Commercial, to achieve regulatory objectives.