Develop and implement regulatory strategies for new product development and lifecycle management.
• Prepare, review, and submit regulatory dossiers (CTD/eCTD format) for FDA, EMA, and other global regulatory authorities.
• Coordinate and manage communications and responses to regulatory agencies.
• Monitor and interpret global regulatory changes and assess the impact on the company’s products and processes.
• Support labeling, advertising, and promotional material review to ensure compliance with regulations.
• Represent Regulatory Affairs on cross-functional project teams and guide regulatory requirements.
• Maintain regulatory documentation and databases by internal SOPs and external requirements.
• Provide mentorship and guidance to junior regulatory staff.
• Participate in audits and inspections as the regulatory representative.