Regulatory Affairs Officer

Role & responsibilities

Dossier and regulatory document preparation

Regular discussion and interactions with customer's regulatory team to answer queries regarding documentations

Visiting FDA office for follow ups on applications

Preferred candidate profile

• Deep knowledge of regulatory frameworks in Southeast Asia (especially the ACTD structure), Africa, and Latin America, and ability to interpret country-specific requirements for dossier submissions.
• Proficiency in preparing, compiling, and presenting regulatory dossiers (including administrative, quality, nonclinical, and clinical sections) according to the ACTD and local formats.
• Strong documentation management, including version control, secure record-keeping, and familiarity with electronic submission platforms (e.g., eCTD tools).
• Familiarity with ONDLS Portal