Regulatory Affairs Officer

Key responsibilities

• Prepare, compile, and submit regulatory documentation and applications to pharmaceutical regulatory authorities, including product registrations, amendments, and compliance reports
• Ensure all regulatory submissions are complete, accurate, and submitted within required timelines to maintain product approvals and market access
• Monitor changes in pharmaceutical regulations, guidelines, and industry standards, and communicate these changes to relevant internal stakeholders
• Liaise with regulatory agencies to address queries, requests for additional information, and other regulatory correspondence
• Maintain and organise regulatory files in accordance with regulatory requirements and company policies, ensuring proper documentation and traceability
• Support the development and implementation of regulatory strategies for new product launches and product line extensions
• Conduct compliance audits and assessments to identify gaps and ensure adherence to regulatory requirements
• Collaborate with quality assurance, research and development, and commercial teams to align regulatory requirements with business objectives
• Provide regulatory guidance and training to cross-functional teams on regulatory requirements and best practices
• Track regulatory timelines, deadlines, and renewal dates to ensure continued product compliance and market authorisation

About you

• Bachelor's degree in Pharmacy or a related course
• Experience in regulatory affairs, pharmaceutical compliance, or a related regulatory function within the pharmaceutical or healthcare industry
• Strong knowledge of Philippine Food and Drug Administration (FDA) regulations and requirements, as well as familiarity with other regulatory frameworks
• Excellent written and verbal communication skills, with the ability to prepare clear and comprehensive regulatory documentation
• Attention to detail and strong organizational skills, with the ability to manage multiple regulatory projects simultaneously