Job Title: Regulatory Affairs Executive

Job Location: Iskcon, Ahmedabad

Job Summary

The Regulatory Affairs Executive will be responsible for preparing, reviewing, and managing regulatory documents and dossiers for product registrations in domestic and international markets. The role involves coordinating with manufacturers, customers, and regulatory authorities to ensure timely submission and approval of regulatory applications.

Key Responsibilities
- Prepare, compile, review, and submit regulatory dossiers and registration documents.
- Coordinate with manufacturers and customers for collection of required regulatory documents.
- Handle product registrations, renewals, variations, and regulatory submissions in assigned markets.
- Review technical documents such as CTD, ACTD, product specifications, COA, stability data, and manufacturing information.
- Maintain regulatory databases, trackers, and document records.
- Ensure timely submission of responses to regulatory queries and deficiencies.




- Coordinate with internal departments and external partners for regulatory requirements.
- Monitor changes in regulatory guidelines and ensure compliance with applicable regulations.
- Support Business Development and Export teams with regulatory documentation for current projects.
- Maintain confidentiality and accuracy of all regulatory information and documents.

Qualification, Experience & Skills
- Bachelor's Degree in Pharmacy or Master's Degree in Pharmacy.
- 2–4 years of experience in Regulatory Affairs within the pharmaceutical industry.
- Knowledge of CTD, ACTD, dossier preparation, and international registration requirements.
- Understanding of pharmaceutical regulations, documentation, and compliance requirements.
- Good communication, coordination, and document management skills.
- Proficiency in MS Office applications, especially Word, Excel, and PowerPoint.
- Strong attention to detail and ability to manage multiple projects within timelines.

📌 Regulatory Affairs Executive (Ahmedabad)
🏢 Aliyan Pharmaceuticals
📍 Ahmedabad