Regulatory Information Management Consultant

England  ‐ Onsite
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Description

EPM Scientific are currently seeking a Regulatory Specialist to work with one of their key Pharmaceutical clients on a remote basis and a full-time contract.

This position is an initial 6-month contract with a strong liklihood of an extension.

Please see a small job description below:* Maintaining serialisation system for FMD (TraceLink) including Alert management
* Support Computer Systems Validation work for RIMS systems
* Maintain data in Product Directory - data input and revision - all product classifications
* System administration and project support for SharePoint based Document management system
* Training and supporting new Regulatory copy approval process in SharePoint system
* Maintenance of Home Office Controlled Drugs and Precursors licences
* Publishing support - arranging eCTD publishing with 3rd party provider plus some pre-publishing work
* Maintaining mailboxes for Regulatory teams
* Reviewing and approving product requests in ERP system and providing regulatory data to support SKU creation in ERP
* Maintaining Regulatory trackers
* Maintenance and submission of xEVMPD entries in Article 57 database
* Providing data to Pharmacovigilance team to support PSMF

If you are available and looking for your next opportunity please apply to this position below!
Start date
03/2022
Duration
6 Months
From
EPM Scientific
Published at
08.03.2022
Project ID:
2335511
Contract type
Freelance
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