Regulatory Affairs Associate

Role & responsibilities

A Regulatory Affairs Associate to support the regulatory affairs team in preparing and managing

regulatory documentation and dossiers for product approvals.

Key Responsibilities

Assist in compilation of regulatory dossiers as per CTD/ACTD format

Support preparation of regulatory documentation for submissions

Track regulatory timelines and submission/approval status

Coordinate with cross-functional teams (QA, R&D;) for document collection

Maintain regulatory files and correspondence with authorities

Support labelling and artwork review as per regulatory guidelines

Stay updated with Pharma Regulatory guidelines and requirements

Preferred candidate profile

Basic knowledge of MS Office (Word, Excel, PowerPoint)

Good written and verbal communication skills

Attention to detail and documentation discipline

Willingness to learn and work in a regulated, compliance-driven environment