Regulatory Publishing Specialist

Freyr Solutions; India; On-site; INR 700,000 - 1,000,000; Full time

Job summary

Freyr Solutions in India is seeking a Regulatory Submissions Associate to support regulatory teams through all administrative and technical steps of submissions, aligned with global procedures. You will prepare and dispatch documentation packages, ensure eCTD lifecycle maintenance per ICH and regional specs, and update submission data in regulatory information systems to maintain compliance.

Maintain liaison with cross-functional regulatory functions and stakeholders, and escalate issues as

Responsibilities

• Support regulatory teams during submission processes in all administrative and technical steps according to global procedures
• Prepare and dispatch/submit documentation packages for predefined submission types and regions in compliance with Health Authority requirements
• Ensure eCTD lifecycle maintenance according to ICH and regional specifications
• Ensure timely update of submission data in regulatory information management databases and verify data is compliant
• Be involved in processing regulatory documents like M1, eApplication Form, COPPs, GMP Certificates
• Maintain communication with regulatory functions (RER, RGLI, RGL) and country organizations and non-regulatory stakeholders per guidance
• Ensure escalation procedures are followed in case of issues and delays
• Might participate in document preparation activities like scanning, bookmarking, linking to ensure submission readiness
• Might participate in document bulk upload activities
• Contribute to Internal / HA driven audits and inspections

Job description

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 efficient 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.