- Prepare and compile regulatory documentation, including dossiers, submissions
- Analyze and interpret regulatory guidelines, requirements, and industry standards to ensure organizational compliance
- Support the preparation and submission of regulatory applications to relevant authorities
- Conduct regulatory research and gap analysis as per Regulatory requirements and guidelines
- Collaborate with cross-functional teams including quality assurance, product development, and operations to gather necessary information for regulatory submissions
- Monitor changes in regulatory requirements and communicate updates to relevant stakeholders
- Assist in authoring dossier sections, query responses, variation applications
- Maintain knowledge of current Positive Pharmaceutical Practices (GPR) and ensure adherence across assigned projects
- Support the organization's regulatory compliance program through documentation, tracking, and reporting
- Regulatory Life cycle management