Regulatory Affairs Specialist

About This Role

Supporting the export drug registration process is the core of this Regulatory Affairs role, working under the Head of Regulatory Affairs. The position involves CTD/ACTD dossier compilation, CDSCO documentation, and registration tracking for active and target export markets. Being based at the manufacturing plant allows for direct collaboration with QA/QC and production teams to gather necessary data.

Responsibilities

• Support CTD/ACTD dossier compilation and documentation for export registration
• Assist with CDSCO-related paperwork, including WHO-GMP certification, COPP applications, and export NOCs
• Track registration status across export markets (Africa, Middle East, CIS, South-East Asia) and flag pending items
• Coordinate with QA/QC and plant teams to pull stability data, batch records, and COAs needed for submissions
• Maintain organized, submission-ready documentation under the Head of RA's review
• Learn the end-to-end registration process by working closely with senior RA and plant leadership

Requirements

• 0 -4 years of experience in pharmaceutical regulatory affairs, quality, or a related pharma function (freshers with a strong academic background are welcome to apply)
• B.Pharm / M.Pharm or equivalent
• Basic familiarity with CTD/ACTD documentation or willingness to learn quickly
• Detail-oriented, organized, and reliable with documentation and deadlines

Benefits

• Real, hands-on regulatory experience at a WHO-GMP certified export manufacturer
• Faster learning through direct access to QA/QC, production, and batch data by being on-site at the plant
• Clear growth path into more senior regulatory responsibility