Regulatory Affairs Officer

Ce Chem Pharmaceuticals; Bengaluru; On-site; INR 600,000 - 900,000; Full time

Job summary

Ce Chem Pharmaceuticals in Bengaluru seeks a regulatory dossier specialist to lead compilation and submission of regulatory documents across Southeast Asia, Africa and Latin America. The role focuses on ACTD-aligned dossiers and clear communication with clients.

You will manage document control, coordinate with cross-functional teams, and interact with regulatory authorities to resolve queries, aiming for timely approvals and compliant submissions through eCTD tools and ONDLS Portal.

Qualifications

• Regulatory dossiers must be prepared and presented per ACTD and local formats.
• Extensive knowledge of Southeast Asia, Africa and Latin America regulatory requirements.
• Experience preparing administrative, quality, nonclinical and clinical dossier sections.
• Proficient with electronic submission platforms and strict version control.

Responsibilities

• Dossier and regulatory document preparation.
• Regular discussions with customer regulatory teams to answer queries.
• Visit FDA office for follow ups on applications.

Skills

Regulatory frameworks knowledge

Interpret country-specific dossier req

ACTD dossier preparation

Documentation management

Electronic submission platforms

Tools

eCTD tools

ONDLS Portal

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