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Job Details

Senior Regulatory Operations & Publishing Officer / EU & ROW

Company: Turner Regulatory
Location: Buckinghamshire
Reference: 10073-1
Closing Date: 31 Aug 17
Type: Permanent
Salary (£): 40,000 - 60,000
Benefits: Bonus and good benefits

Job Summary:

Regulatory, Operations, Publishing & Submissions. EU & EMEA region.


Weary of your current Regulatory Operations/Publishing role? This fast-growing Pharma has an exciting Regulatory Operations/Publishing/Submissions role for a candidate with 3-5 year's experience. From a career point of view, this could represent ideal career progression. Europe, and ROW/International remit. Buckinghamshire location.

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 Publishing, Operations and Submissions. EDMS familiarity.

The position is based in Buckinghamshire. This outstanding Pharma offers a top-end package to the right candidate, this includes competitive salary, good bonus and leading benefits.

If you are interested in this, or any other Regulatory Affairs roles, please get in touch with Julian Turner, at Turner Regulatory Recruitment, on 0203 695 9477/07447 977 330,, or submit an application by clicking Apply Now.

Apply for this job: Senior Regulatory Operations & Publishing Officer / EU & ROW

Contact Information:

Address:  Head Office
71-75 Shelton Street
Covent Garden
Tel:  0203 695 9477
Website:  Visit Our Web Site

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