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Ce Chem Pharmaceuticals
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Regulatory Affairs Officer

Regulatory Affairs Officer

Ce Chem Pharmaceuticals

5 - 10 years

|

3 - 8 Lacs

Posted:1 day ago| Platform:

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Skills Required

dossier preparation drug regulatory affairs regulatory affairs row market regulatory documentation actd regulatory submissions

Work Mode

Work from Office

Job Type

Full Time

Job Description

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

More Jobs at Ce Chem Pharmaceuticals

Regulatory Affairs Officer

bengaluru

INR 3 - 8 Lacs

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Ce Chem Pharmaceuticals

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