Key Responsibilities

• Lead and manage mid- to small-scale global regulatory submission projects, ensuring timely and compliant delivery
• Provide strategic input and regulatory intelligence to support global product development, registration, and lifecycle management
• Collaborate with cross-functional teams to implement and optimize global systems, tools, and processes for regulatory operations
• Ensure documentation complies with internal standards and external regulatory requirements, including formatting and retention policies
• Coordinate the preparation, review, and assembly of high-quality regulatory dossiers and submission components
• Analyze and interpret regulatory data, preparing executive summaries and abstracts to support decision-making
• Build and maintain strong relationships with internal stakeholders and external partners to align regulatory strategies

Essential Requirements

• Bachelor’s degree in life sciences, pharmacy, or a related scientific discipline
• Minimum 3 years of experience in regulatory affairs or related pharmaceutical industry role
• Proven ability to manage regulatory submissions and documentation in compliance with global standards
• Strong understanding of regulatory guidelines and documentation systems
• Experience working in cross-functional and multicultural teams
• Excellent written and verbal communication skills in English
• Strong analytical skills with the ability to interpret complex data and summarize key insights
• Proficiency in documentation tools and electronic records management systems