Regulatory Manager, Operations and Publishing / Top Biotech / London
- Contract Type
If you want to work in Regulatory Operations/Publishing for a dynamic Biopharma in a great location, you are reading the right advert. A highly competitive salary package is offered to the right candidate.
This fast-growing Biotech has an exciting Regulatory Operations/Publishing/Submissions role for a candidate with 5+ year's experience. From a career point of view, this could represent ideal career progression. Europe, and ROW/International remit. Fantastic Central London location. Project Management and managing 1 other staff member.
You will possess good experience and a thorough understanding of Electronic and Paper Publishing – particularly eCTD building. You will prepare a variety of submissions utilizing publishing tools for electronic and paper submission generation: you will possess experience in using either Liquent/InsightPublisher/Manager, or ISI Tools & Publishing/Manager and eCTDXPress. Adobe Lorenz/Docubridge. Full pipeline experience: CTA's, MAA's, European Procedures: National, MRP, DCP and Centralised Procedure. Post marketing activity: Variations and Renewals.
Reporting to the Vice President, the candidate will interface with Regulatory Managers, 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 5+ years in Regulatory Operations, Publishing and Submissions. Some EDMS familiarity.
The position is based in Central London. This outstanding Biotech 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 email@example.com, or submit an application by clicking Apply Now.