Key Responsibilities, Accountabilities and Associated Tasks

- Support regulatory teams during the submission process in all administrative and technical steps according to global procedures
- Prepare and dispatch/submit documentation packages for predefined submission types and region(s) in compliance with Health Authority requirements
- Ensure eCTD lifecycle maintenance according to ICH and regional specifications
- Ensure timely update of submission data in the regulatory information management databases and verify that the data is kept compliant
- Be involved in the timely and effective processing of regulatory, submission-relevant documents like M1,eApplication Form, COPPs, GMP Certificates
- Maintain communication network with regulatory functions like RER, RGLI,



RGL and country organizations and non-regulatory stakeholders according to guidance documents
- Ensure escalation procedures are followed in case of issues and delays
- Might be involved in document preparation activities like scanning, bookmarking, linking and other activities to ensue document submission readiness
- Might be involved in document bulk upload activities.
- Contribute to Internal / HA driven audits and inspections.

Please apply only if you have relevant Veeva Vault / Regulatory Publishing experience and can join immediately or within 15 days.

📌 Regulatory Publishing Specialist (India)
🏢 Freyr Solutions
📍 India