Regulatory Affairs Executive

Job description

Job Summary: Responsible for preparing and submitting regulatory filings to support the registration and lifecycle management of recombinant products in global markets. Ensures regulatory compliance by collaborating with cross-functional teams and maintaining up-to-date regulatory documentation and systems. Key Responsibilities: • Prepare and compile regulatory submissions including IND, IMPD, CTD dossiers, and briefing books for global product registrations. • Update dossiers covering Administrative, CMC, and Clinical information; respond to regulatory agency queries in a timely manner. • Track and maintain regulatory registrations and product lifecycle data to ensure compliance with global regulations. • Develop and submit variation packages for ongoing lifecycle management of approved products. • Monitor and interpret changes in regulatory guidelines and approval processes worldwide. • Conduct regulatory impact assessments for product or process changes. • Support regulatory audits conducted by customers and Ministry of Health (MOH). • Perform gap analysis and review clinical and CMC documentation to support regulatory submissions. Skills & Competencies: • Strong knowledge of global regulatory requirements and submission formats (FDA, EMA, ICH guidelines). • Hands-on experience with preparation of IND, IMPD, CTD dossiers and regulatory documentation. • Detail-oriented with excellent document management skills. • Effective communication and coordination with cross-functional teams. • Analytical skills to assess regulatory impacts and address compliance issues. • Ability to work independently and manage multiple regulatory activities simultaneously. Proficiency with regulatory submission tools and tracking systems. Education Qualification: Master’s Degree in Life Sciences, Pharmacy, Biotechnology, or related discipline. Experience: • 2 to 4 years of experience in regulatory affairs, ideally with exposure to recombinant or biologic products.