Job Description

Regulatory Co-ordination Manager - 1 year Contract Role - Home working available

Location: Based in the Netherlands commutable from Amsterdam, Leiden, Haarlem, The Hague, Rotterdam, Gouda

My client is a global Biotechnology company with strong sales and a great company culture focused on innovation and personal development for all.  They are currently expanding their EU and global regulatory function and have a requirement for a motivated regulatory professional to join the team as a Regulatory Business Process Co-ordinator / Manager.

You will play a key role in defining and supporting the submission portfolio management process across multiple products and therapeutic areas with interaction with Snr RA Project Managers and Regulatory Line Managers for a variety of sometimes complex and diverse challenges with decision-making that impacts multiple projects. As a Business Process Coordinator your focus is on the EMEA region; but you will liaise with global colleagues, senior management and Global Project Teams.

Projects are varied and will include hands-on involvement in the interpretation of health authority regulations, product change control activities, Labeling/labelling changes, submission publishing/dispatch and/or registration tracking.  You will manage multiple projects and accurately document change and ensure all approval requirements are met before releasing product quality, patient safety, and in some cases, product sales.

Personal experience/qualifications needed

• Bachelor’s degree (scientific discipline preferred)
• Familiarity with one or more key regional Health Authority regulations, interpreting regulatory guidance and monitoring the external regulatory environment for changes that impact submission standards or other regulatory practices
• Experience with eCTD, NEES and other technical submission formats
• Experience with one or more European procedure types, e.g. CP, MRP/DCP
• Experience with lifecycle maintenance, submission management and document management concepts
• At least 4 years of previous industry experience within Regulatory Affairs, or Regulatory Operations.

Please note if this role isn’t for you but you know someone who might like this role, we offer a great referral bonus for any of your friends or colleagues that we help to find a new role!

To Apply!

To apply for this role, please press the red “Apply for position” button, or contact Theo Moore on +44 (0)207 801 3384 in full confidence to receive more details on this role or to hear about other available opportunities in Regulatory Affairs.

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