Regulatory Affairs Associate

Creating Possible drives everything we do. It’s evident in our mission and core values. This is how we built a culture of excellence that is fuelled by a passion for improving the lives of people around the world and advancing the care of patients suffering from life-threatening diseases worldwide.

The Virology team provides strategic and technical advice from development throughout the whole product lifecycle for all HIV, Hepatitis and Emerging Viruses projects/products. The team’s core activities are to plan, prepare and progress new product registrations and subsequent post-approval safety and indication updates. We work cross-functionally with a diverse number of stakeholders both internally and externally to Gilead.

The team works on a broad portfolio of products and can offer the opportunity to work on a diverse range of regulatory activities. The team and regulatory department as a whole is built on a strong sense of team work.

We currently have an exciting opportunity for a Regulatory Affairs Associate II in the Virology IC & GPS team to support the HIV portfolio, working with highly experienced regulatory professionals across the whole product lifecycle. The IC& GPS team is responsible for Intercontinental and Global Patient Solutions which includes territories throughout Asia, Latin America, Africa, Eastern Europe and the Middle East. This role will be based in our Cambridge office.

Responsibilities

• Responsible for supporting and assisting the prepartion of submissions for designated products in the region. These activities may range from new product licenses to lifecycle activities and support all regulatory aspects of the application.
• Partner within Global Regulatory Affairs and the Development organization to operationally support delivery of the agreed strategy.
• Establish relationships with Gilead affiliates and distributor partners and serve as point person to these key stakeholders.
• Prepare and maintain labelling to support MAAs and other post-licensing activities.   
• Support updates to the Product Company Core Data Sheet (CCDS) are implemented in a timely manner. 
• Liaise with regulatory, manufacturing and other parties as appropriate, to ensure that updates to the product packaging components are implemented in line with approved labelling in line with approved labelling and agreed timelines
• Participate and contribute to regulatory team meetings and present project status updates.
• Use and update regulatory information systems for planning, preparing, tracking and storing submissions to regulatory agencies.
• May participate in efforts across function in process improvements initiatives

Competancies

• Understanding of regulatory requirements and an appreciation of Regulatory Affairs.
• Strong organizational skills and ability to work on multiple projects with tight timelines.
• Strong communication skills both in writing and verbally
• Methodical attention to detail
• Must have a “can do” attitude and be “hands on” as and when required
• Ability to plan, prepare and deliver regulatory submissions
• Embrace, and thrive in, a diverse team 
• A driven self-starter
• Able to take personal ownership and initiative

Education

• Life Science degree
• Some regulatory experience is desirable but not essential.