Senior Regulatory Affairs Associate

The Company

My client, a biopharmaceutical that develops cancer immunotherapy products is seeking a Senior Regulatory Affairs Associate to work closely with their European Regulatory lead.

The Position

As the new Senior Regulatory Affairs Associate you will report to the European Regulatory Lead and prepare regulatory documentation for the development product and coordinate regulatory documentation to support clinical trial applications and amendments, in the European Union. You will interact with the Regulatory, clinical research, clinical operations and other functions to ensure optimal execution of the agreed regulatory strategy for development medicinal products.

As part of the remit, you will also:

• maintain a working knowledge of regulatory requirements and guidelines and for communicating changes in regulatory information to product teams.
• Represent the International Regulatory Affairs function at cross functional submission and study management team meetings.
• Support the Associate Director as required.

The Person

The ideal Candidate will be degree qualified and have experience in the preparation and submission of regulatory documentation to support centralised MAA procedure and post approval activities and a good breadth of understanding of the European regulations. You will have Excellent communication skills both in writing and verbally with the ability to work under minimal supervision of Regulatory Affairs professionals but following detailed instruction with well-defined procedures.

As part of the individual requirement, the following is desirable:

• Knowledge and experience relating to clinical trials.
• Experience representing Regulatory Affairs on cross functional teams.

Compensation

£45,000-£50,000

Competitive benefits package.

To discover more about this opportunity, apply now or contact David Maguire on 020 3873 7067 or email Dmaguire@I-Pharmconsulting.com for a confidential discussion.