Regulatory Affairs Publishing Consultant "CONTRACT ROLE"- The Netherla
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Regulatory Affairs Publishing Consultant "CONTRACT ROLE"- The Netherlands - 12 months Excellent rate for a Global Pharma Co.
This is an excellent role where you will be joining a pro-active and highly regarded Regulatory operations team for a leading global Pharmaceutical company based in The Netherlands.
Initially this will be for 6 months, but with a high chance that the contract will be extended to 12 months. This is a broad based role which will include all aspects of regulatory operations but with an initial primary focus on registrations and planning. You will be pproviding global expertise on regulatory authorities' requirements on technical/format aspects of submissions worldwide for electronic document management, submission compilation, publishing and lifecycle.
You will be provide publishing support to cover:
eCTD publishing of lifecycle submissions Non-eCTD publishing (such as protocols, PSUR, CSR, etc) Remediation of source documents and QC of publishing output Process development and documentation as needed Preparation of electronic regulatory submissions Assisting in the development and implementation of regulatory documentation standards and procedures related to electronic publishing Awareness of regional regulatory requirements related to electronic regulatory submissions to EMEA
Good working knowledge of industry standard publishing tools (with a preference for ISIPublisher, eCTDXPress, ISI Toolbox) Experience with working in Documentum A solid understanding of eCTD publishing Experience with general publishing tasks
If this role is for you, but you have a colleague who you think would be a great match, then please lets us know as offer an Ipad 3 for any referral that leads to a placement.
To Apply for this role, please send your CV with a covering note to or alternatively, to have a confidential discussion about this or other potential roles or career options, call Theo Moore or Matt Greig in the London office on (0).
Advanced Regulatory is a division of Advanced Search and Selection Ltd and has been operating since 2004. We are registered and licensed to recruit through the United Kingdom, mainland Europe and the Americas - we have offices both in the UK and in Switzerland. We are a recruitment business dedicated to the pharmaceutical industry, specialising in Regulatory Affairs.
We match professional candidates to the best permanent, contract and interim roles in the market. For more information about the company visit us at .
We provide a high level of service because we believe this matters. Regulatory professionals will find we know our recruitment subject matter.