Job Description

Regulatory / Regulatory Affairs Manager CTA submissions, Brussels

We have a 6 months contract opportunity for a Regulatory Affairs Manager / Consultant with a dynamic, international Biopharmaceutical company based in Brussels, Belgium. 

Work with a growing business in a positive and friendly team environment. A competitive hourly pay is on offer here for the right candidate.

In this role you will:

• Manage Clinical Trial Applications in the EU to agreed project targets
• Provide operational regulatory support and guidance
• Support the Regulatory Affairs Lead in the planning, preparation and delivery of timely submissions for biologics
• Oversee the work of the assigned CROs.

The ideal candidate will have:

• 3 to 5 years or more hands-on experience with CTAs in the EU, having assisted in the review and preparation of IMPDs and other CTA documents
• You will have the ability to overcome obstacles, be result focused, analytical in your approach and work effectively in ambiguous situations.

In return you will:

• work for a leading, science based Biopharmaceutical company with an impressive R&D
• work closely with and be supported by an experienced Regulatory Affairs Leader
• support clinical trial submissions and follow-up activities for biological products
• have the flexibility to work from home 1-2 days per week.

This contract is likely to be extended to 12 months. 

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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