Senior Regulatory Affairs Associates, 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 are looking to fill the following positions:

• Senior Regulatory Affairs Associate / Associate Manager, Hepatitis C
• Senior Regulatory Affairs Associate / Associate Manager, Oncology
  

  Responsibilities & Accountabilities

• Preparation of regulatory submissions for investigational products and commercial medicinal products.
• Preparation and maintenance of regulatory documentation such as IMPDs to support Clinical Trial Applications, amendments, scientific advice procedures and Paediatric Investigational Plans (PIP) for investigational medicinal products.
• Liaising with regulatory staff in the affiliates and with distributors.
• Assisting in the preparation of Marketing Authorisation Applications (MAAs) for new products in development.
• Preparing non-clinical, clinical and safety regulatory documentation, as required, in accordance with regulations, post licensing commitments and legal obligations of the marketing Authorisation Holder via the European Centralised procedure, e.g. renewals, variations, responses to questions, Follow-up Measures, PSURs etc.
• Providing input on the label and ensuring product packaging and associated information is updated and maintained, as required, in accordance with Marketing Authorisations in Cambridge-responsible territories including the review and provision of accurate labeling translations.

Experience, Skills and Knowledge

The successful candidate will be degree educated in a scientific discipline and will have relevant experience within Regulatory Affairs. An advanced degree such as a PhD would be an asset. Candidates must have experience in the preparation and submission of regulatory documentation to support clinical trial applications and amendments in the European Union and a good breadth of understanding of European regulations relating to clinical trials. 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.

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