- Basic knowledge of CTD/ACTD dossier compilation and regulatory documentation
- Prepare and manage regulatory dossiers, track submission timelines, coordinate with QA and R&D;, maintain regulatory files, support labeling review
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)
Valuable written and verbal communication skills
Attention to detail and documentation discipline
Willingness to learn and work in a regulated, compliance-driven environment