13 Oct
|
Ce-chem Pharmaceuticals
|
Bengaluru
13 Oct
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