Senior Regulatory Publisher in London

10 Jun 2019
10 Jul 2019
Mary Bolt
Regulatory Affairs
Full Time
Contract Type
Experience Level
Senior Management
Mary Bolt at CK Group is recruiting for a Senior Regulatory Publisher to join one of the worlds biggest CROs at their site based in Central London on a permanent basis.

The Company:
Our client is a well known, global CRO that work across a large number of countries worldwide helping their clients bring to market vital medicines including blockbuster drugs.

This role is located in Central London and the site is easily commutable by tube as well as having strong public transport links with surrounding counties. 

The Role:
Your main duties will be to:
- Be responsible for providing publishing and submission support in the development of global Regulatory submissions.
- Directly communicate project specifics to internal and external clients and organise, compile and publish documents and submissions for regulatory deliverables.
- Act as primary publisher for all worldwide regulatory submission types e.g. electronic, paper according to SOPs and within established timeframe's requiring no technical direction as well as setting submission strategy for complex solutions.

Further responsibilities will include:
- Providing oversight to strategic planning and publishing timeframe's required for a specific submission and promoting submission publishing efficiencies by promoting re-use of documents, adopting global dossier principles and standardising processes to enable simultaneous compilation and publication of submissions.
- Collaborating with other submission publishers to assure standard practices and quality submission outcomes, participating in multi-discipline work streams as publishing subject matter expert and educating document authors on technical submission formats, lifecycle management and regional submission requirements.
- Acting as submission coordinator on project teams for functional or cross-functional submissions of high complexity and performing Quality Control review of submission component documents to client and regulatory agency specifications.

Your Background:
The ideal candidate for this role will have:
- Educated to degree level or above in life science or a related field with an extensive background in global publishing including eCTD, NeeS and paper submissions.
- In depth knowledge of regulations governing pharmaceutical document submissions and excellent skills in the use of electronic submission publishing tools and/or document management systems.
- Excellent communication, interpersonal and time management skills and the ability to work autonomously under limited direction.

Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.

CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.

If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 45583 in all correspondence.

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