Regulatory Affairs Associate

Airvin Skills; Chennai District, Thiruvananthapuram; Hybrid; INR 500,000 - 700,000; Full time

Job summary

Airvin Skills in Chennai, Tamil Nadu, India, seeks a Regulatory Affairs Associate to support the regulatory affairs team in preparing and managing regulatory documentation and dossiers for product approvals.

You will assist in compile dossiers, prepare submissions, track timelines, coordinate with QA and R&D, maintain files, and stay updated with regulatory guidelines. The role requires attention to detail and strong communication in a regulated environment.

Qualifications

• 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.

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.

Skills

Communication skills

Attention to detail

Documentation discipline

Tools

MS Office

Job description

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