Life Science Capabilities / National Regulatory Affairs
Focus on optimizing efficiency and ensuring pharmaceutical products comply with regulatory standards.
Regulatory Pathway Planning
Compliance Monitoring
Regulatory Intelligence and Liaison
Post-Market Surveillance
Risk Management
Cross-Functional Collaboration
Develop strategies for product development and market entry based on regulatory landscapes.
Plan regulatory submissions and interactions with regulatory agencies to align with business objectives.
Liaison between the company and stakeholders, addressing queries, negotiating requirements, ensuring clear and effective communication.
Ensuring ongoing compliance with regulatory requirements throughout the product lifecycle.
Assess the impact of regulatory changes on the company's products and operations.
Manage activities such as audits, regulatory agency inspections, or product recalls.
Interpret and apply regulatory guidelines and requirements to various stages of product development.