Ce Chem Pharmaceuticals

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