Regulatory Publishing Specialist

Key Responsibilities, Accountabilities and Associated Tasks

1. Support regulatory teams during the submission process in all administrative and technical steps according to global procedures

2. Prepare and dispatch/submit documentation packages for predefined submission types and region(s) in compliance with Health Authority requirements

3. Ensure eCTD lifecycle maintenance according to ICH and regional specifications

4. Ensure timely update of submission data in the regulatory information management databases and verify that the data is kept compliant

5. Be involved in the timely and efficient processing of regulatory, submission-relevant documents like M1,eApplication Form, COPPs, GMP Certificates

6. Maintain communication network with regulatory functions like RER, RGLI, RGL and country organizations and non-regulatory stakeholders according to guidance documents

7. Ensure escalation procedures are followed in case of issues and delays

8. Might be involved in document preparation activities like scanning, bookmarking, linking and other activities to ensue document submission readiness

9. Might be involved in document bulk upload activities.

10. 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.