Job Posted: 21 Feb 2017

Senior Regulatory Operations / Publishing Associate - top salary

£42,000 to £52,000, bonus and benefits| Cambridgeshire| Permanent

Do you want to work for one of the best employers in the industry? This top Biopharma has an exciting Regulatory Operations/Publishing/Submissions role for a candidate with 3-5 year’s experience. From a career point of view, this is an outstanding company to get on your CV.

You will possess good experience and a thorough understanding of Electronic and Paper Publishing – eCTD building and NeeS. You will prepare a variety of submissions utilizing publishing tools for electronic and paper submission generation: you will possess experience in using ISI Tools & Publishing/Manager, eCTDXPress, and/or InsightPublisher/Liquent. Adobe Lorenz/Docubridge. Full pipeline experience: CTA’s, MAA’s, European Procedures – National, MRP, DCP and Centralised Procedure. Post marketing activity – Variations and Renewals.

The candidate will interface with Regulatory Project Managers, Regulatory Product Managers and Authors to provide guidance on submission preparation. The role entails taking the lead in submission planning meetings when required, and assist and provide training for others on software tools in order to educate authors on publishing policies and procedures. The candidate will operate as a quality control filter of Regulatory documents generated by Regulatory Affairs and Clinical Research. Assist with the development and management of projects within a Regulatory Operations context.

The successful candidate will possess 3-5 years in Regulatory Operations, Submissions and Publishing. EDMS familiarity.

The position is based in Cambridgeshire. This outstanding Biopharma offers a top-end Salary package to the right candidate, this includes high Salary, good bonus and leading benefits. 

Relocation assistance is available for overseas applicants.

If you are interested in this, or any other Regulatory Affairs roles, please get in touch with Julian Turner, at Turner Regulatory Recruitment, on the number provided, Email, or submit an application by clicking Apply Now.