07 Nov
|
Ce-chem Pharmaceuticals
|
Bengaluru
07 Nov
Ce-chem Pharmaceuticals
Bengaluru
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.
Solid documentation management, including version control, secure record-keeping, and familiarity with electronic submission platforms (e.g., eCTD tools).
Familiarity with ONDLS Portal
📌 Regulatory Affairs Officer Bengaluru
🏢 Ce-chem Pharmaceuticals
📍 Bengaluru