Regulatory Affairs Manager- Virology

Regulatory Affairs Manager- Virology
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. Gilead’s 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 company’s five core values. That’s 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 worldwide.

An exciting opportunity has arisen for a Manager to join the Virology team within Global Regulatory Affairs. We are looking to hire an experienced professional who is passionate about advancing therapeutics and making a difference to the lives of patients.

This role will be responsible for supporting products within the HIV and Emerging Viruses portfolio, including leading post-approval submissions via the EU centralised procedure and supporting products in early phase development.

As part of the Virology 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 you will be involved with. Each role within the team is highly visible and has a direct impact on bringing Gilead's therapeutics to patients.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following:

• Interact with the Global Regulatory Leads to ensure optimal execution of the agreed regulatory strategy for approved and investigational medicinal products
  
• Act as Regulatory Project Team representative for specified products
  
• For approved medicinal products, lead, develop and co-ordinate the submission of non-clinical, clinical and safety regulatory documentation via the European Centralised procedure, e.g. Type I and Type II variations, line extension applications, responses to questions, renewals, PSURs etc.
  
• For investigational medicinal products, lead, develop and co-ordinate the submission of applications to support early phase development, including Clinical Trial Applications/ amendments and Paediatric Investigation Plans
  
• Contribute to local and / or global process improvements which have a significant impact on the business.
  

CORE COMPETENCIES

• Excellent verbal and written English communication skills and demonstration of excellent interpersonal skills are required.
  
• Excellent planning and organisational skills with the ability to work simultaneously on a number of projects with tight timelines
  
• Demonstrated effectiveness in cooperation and teamwork with analytical and assessment skills.
  
• Planning and information seeking skills and ability to work on specific tasks with minimal supervision.
  
• Problem solving, strategic thinking skills with ability to impact and influence
  
• Experience in developing and implementing regulatory strategy
  
• Attention to detail with accuracy and quality
  

KEY ROLE-RELATED COMPETENCIES

• Able to facilitate/impact and influence effective planning interactions and discussions
  
• Able to effectively interact with external parties to information gather and effectively drive projects through to completion to tight timelines
  
• A good scientific background and understanding with the ability to acquire this knowledge in a short timeframe
  

EDUCATION and/or EXPERIENCE REQUIRED

• Life Science degree and demonstrated relevant regulatory affairs experience
  
• Good knowledge of regulatory requirements for the EU centralised procedure
  
• Experience in post-marketing submissions via the EU centralised procedure is desirable.
  
• Experience in clinical trial applications/amendments in the European Union and good breadth of understanding of European regulations relating to clinical trials would be advantageous.
  

COMPANY CORE VALUES

• Teamwork, Excellence, Accountability, Integrity, Inclusion
  

LOCATION

You can be based at Stockley Park or Cambridge office

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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