Regulatory Affairs Specialist

About the Role

We are looking for a Regulatory Affairs Specialist to support the drug export registration process at our manufacturing facility located in Raipur, Chhattisgarh. In this full-time, onsite position, you will work closely with the Head of Regulatory Affairs and cross-functional teams such as QA/QC and production. This hands-on role offers an excellent opportunity to gain real-world experience in pharmaceutical regulatory affairs with senior mentorship to help you grow professionally.

Key Responsibilities

• Assist in compiling CTD/ACTD dossiers and preparing documentation necessary for export drug registrations.
• Support CDSCO-related procedures, including WHO-GMP certification, COPP applications, and export NOC preparation.
• Monitor and report on registration statuses for export markets including Africa, the Middle East, CIS, and South-East Asia, highlighting pending actions.
• Collaborate directly with QA/QC and production teams to collect data such as stability studies, batch records, and Certificates of Analysis required for submissions.
• Maintain accurate and well-organized submission files reviewed by the Head of Regulatory Affairs.
• Engage in learning the complete registration process by working with senior regulatory personnel and plant leadership.

Candidate Requirements

• Possess 0 to 4 years of experience in pharmaceutical regulatory affairs, quality assurance, or a related pharmaceutical function; fresh graduates with a strong academic record are encouraged to apply.
• Hold a B.Pharm, M.Pharm, or an equivalent degree.
• Have a basic understanding of CTD/ACTD dossier preparation or demonstrate a strong willingness to learn these processes promptly.
• Be willing and able to work onsite in Raipur adjacent to the manufacturing facility.
• Show strong attention to detail, organizational skills, and dependability regarding documentation management and meeting deadlines.

Why Join Us?

• Gain authentic, hands-on regulatory affairs experience within a WHO-GMP certified pharmaceutical export manufacturer environment rather than a remote or back-office role.
• Benefit from being on-site, enabling direct, timely access to production data and quality assurance teams, accelerating your learning.
• Follow a clear career advancement trajectory toward increasing responsibility in regulatory affairs as you demonstrate capability and growth.