Senior Regulatory Affairs Associate, CMC, Cambridge

Gilead Sciences is a leading biopharmaceutical company whose mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in California, the company has expanded rapidly over the past two decades, with record annual revenues in 2011 exceeding $8 billion, operations spanning four continents, and a staff of approximately 4,300 employees.

Gilead Sciences is in an exciting phase of development, with a growing focus in oncology and hepatitis C alongside its established areas of focus which include HIV, Hepatitis B and serious respiratory and cardiovascular conditions. As part of this growth, we are expanding our dedicated International Regulatory Affairs team in Granta Park, Cambridge. We are looking for experienced Regulatory Affairs professionals who thrive in fast-paced environments and who align with Gilead’s core values ― being accountable, displaying integrity in everything they do, thriving in a team environment, and seeing excellence as the only measure of success.

We currently have an exciting opportunity for a Senior Regulatory Affairs Associate to join the CMC Regulatory group in Cambridge. This position will provide support to the preparation and coordination of the CMC regulatory submissions for investigational and commercial products.

Responsibilities & Accountabilities

• Prepares and/or coordinates the compilation of redacted rest of the world modules in International markets outside the EU and, where required, quality components of new marketing applications in Europe.
• Assists in the timely preparation of Quality components for investigational medicinal products to support clinical trial applications in the international region.
• Prepares CMC Quality components for renewals, variations and other regulatory submissions in Europe and other International territories in accordance with Corporate objectives or post-licensing commitments.
• Participates in group meetings and presents project status updates and strategic approaches to moderately complex programs/projects.
• May initiate or contribute to local process improvements, which have a significant impact on the working of the Regulatory Affairs function or other departments.

Experience, Skills and Knowledge

Successful candidates will be degree educated in a relevant discipline and will either have experience within CMC Regulatory Affairs or experience within Quality Assurance or manufacturing. Candidates must have excellent communication skills, be able to build networks within the Regulatory team and work under pressure with the ability to prioritize. Candidates must be self-motivated & able to work with a high level of autonomy.

This role is office-based at Granta Park, Abington, Cambridge.

For more information on Gilead Sciences please see www.gilead.com/corporate_overview

To apply or for further information, please email Holly Stedman in the Gilead Talent Acquisition team on: Holly.Stedman@Gilead.com