Job Description

Regulatory Affairs Snr Consultant - 1 year renewable contract - Manage CTAs in EU and RoW - Brussels

This is a new Regulatory Affairs contract role based in Brussels with a global Pharmaceutical company. The length of the contract is 12 months (renewable). The focus of this role will be on leading development projects through managing the liaison with CROs for EU and International Clinical Trials in Phases I, II and III.

The role is based in Brussels and is easily commutable by car or public transport. You will have great flexibility on working hours and also working from home.  Although this is a contract role you will be part of a strong and established team that work cohesively and share a number of project responsibilities.

Role:

• Manage Clinical Trial Applications (CTA’s) in EU and provide operational regulatory support and guidance in cross-functional clinical trial teams (internal and external).
• Manage clinical trial submissions to agreed project targets, and oversee the work of the assigned Contract Research Organization (CRO).
• Work flexibly within the EU team to provide broad operational support and leadership for initial clinical trial applications, Q&A with Authorities/Ethics Committees, study maintenance, amendments, trial closure activities and archiving of trial documents.
• The ideal candidate also has experience with assisting in the review and preparation of protocol/IB/IMPD and other CTA documents.
• Prepare and implement regulatory strategy and operational plans for your assigned projects and have an input in the global regulatory strategy.
• This is a great role because you are part of a strong EU Regulatory Affairs development team interacting with the Regulatory Managers, Snr Managers, Associate Directors and GRL’s on EU and Global development projects in a varied role that will keep you busy and energised.

This is a managerial role and it’s essential to have at least 5 to 10 years’ experience in global regulatory affairs with good working knowledge of clinical development activities.

On offer is a good hourly rate, with flexibility for home working in a really friendly and motivated regulatory team!

To Apply!

To apply for this role, please press the red “Apply for position” button, or contact Oli Dimitrov on +44 (0)207 801 3388 or 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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