Description

• Ensure compliance with regulatory requirements in pharmaceutical product development.
• Prepare and submit regulatory documents for drug registration and marketing.
• Review and evaluate labeling, packaging, and advertising materials for compliance.
• Communicate with regulatory agencies regarding product information and compliance issues.
• Conduct training sessions for internal teams on regulatory requirements and updates.
• Strong knowledge of Philippine FDA regulations, GMP and applicable
• pharmaceutical laws
• Knowledge in ACTD dossier submission
• Familiarity with product registration, labelling requirements and regulatory
• documentation
• Up-to-date knowledge of relevant FDA regulations and guidelines
• Excellent documentation, analytical, organizational and communication skills

Requirements

• Educational Qualifications: Bachelor’s degree in Pharmacy or related field
• Experience Level: 1-3 years of experience in regulatory affairs or related field
• Skills and Competencies: Strong understanding of regulatory guidelines and processes
• Qualities and Traits: Detail-oriented with excellent organizational skills
• Responsibilities and Duties: Ability to work effectively in a team environment
• Working Conditions: Ability to manage multiple projects and meet deadlines