Regulatory Affairs Associate II Oncology and Anti-infectives

Foster City
See job description.
May 27 2021
Life Sciences, Oncology
Position Type
Full Time
Organization Type
Job Type

Regulatory Affairs Associate II Oncology and Anti-infectives
United Kingdom - CambridgeUnited Kingdom - Uxbridge

Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gileads therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

Making an impact on a global scale
Inclusion is one of the companys five core values. Thats because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.

When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible

The impossible is not impossible.

It's simply what hasn't been achieved yet.

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.

We are looking for a unique individual who is passionate about advancing therapeutics and thrives under pressure. This is an exciting opportunity for a Regulatory Affairs Associate II to join the Oncology and Anti-infectives team, which provides leadership and support for the development of Gilead's growing product portfolio in the EU, UK, Australia, Canada, and Switzerland.

This is an opportunity to work on a variety of projects focussing on oncology products in development. As part of the Oncology and Anti-infectives team you will be given opportunities to grow as a regulatory professional, and quickly expand your knowledge and experience through the diverse range of regulatory activities. Each role within the team is highly visible and has a direct impact on helping to meet the company's goal of bringing transformative medicines to patients.

  • Plan submissions and prepare regulatory documentation for Clinical Trial Applications (CTA) and amendments for investigational medicinal products, and attend the Clinical Study Management Team (SMT) meetings, as required.
  • Act as regulatory liaison with Gilead Affiliates and study CROs to oversee, support and maintain CTAs.
  • Participate in regulatory team meetings and present project status updates.
  • Support the preparation of other regulatory submissions for investigational and marketed medicinal products.
  • Use and update regulatory information systems for planning, preparing, tracking and storing submissions to regulatory agencies.
  • Perform document filing and retrieval functions as directed and/or in accordance with departmental procedural documents.
  • Seek assistance from appropriate internal and external resources.
  • Support the Oncology regulatory affairs team as required.
  • May interact with the Regulatory, Clinical Research, Clinical Operations and other functions to ensure optimal execution of the agreed regulatory strategy for development medicinal products.
  • May represent the International Regulatory Affairs function at cross functional submission and study management team meetings.
  • Responsible for maintaining a working knowledge of regulatory requirements and guidelines and for communicating changes in regulatory information to product teams.

  • Excellent oral and written English.
  • Excellent planning and organisational skills with the ability to work simultaneously on several projects with tight timelines.
  • Demonstrated effectiveness in cooperation and teamwork with analytical and assessment skills.
  • Planning and information seeking skills
  • Problem solving mindset.
  • Curious with learning agility
  • Attention to detail with accuracy and quality.
  • Ability to understand and effectively relate to external and internal customers.

  • Life Science degree and demonstrated relevant regulatory affairs experience.

  • Stockley Park or Cambridge.

Equal Employment Opportunity (EEO)
It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual's gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.

For Current Gilead Employees and Contractors:

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