Regulatory Affairs Manager – Oncology & Anti-infectivesUnited Kingdom - UxbridgeRegulatoryRegular
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 Manager 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.
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.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following:
Helps define the regional regulatory strategy for development or marketed products.
Prepares and co-ordinates regulatory documentation to support early phase development, including Clinical Trial Applications, Paediatric Investigation Plans and Agency meetings.
Interacts with cross-functional teams to ensure optimal execution of the agreed regulatory strategy for investigational medicinal products.
Represents International Regulatory Affairs (Int RA) at cross functional submission/study management team meetings.
Supports and potentially leads new indication applications in Gilead's core international markets comprising EU, UK, Australia, Canada, and Switzerland.
Prepares and/or co-ordinates submissions via the EU Centralised procedure. This may include e.g., labelling variations, PSURs/RMPs, responses to questions, renewals.
Assists in ensuring product packaging and associated information is updated and maintained in accordance with marketing authorisations, including the review and provision of accurate labelling translations.
Responsible for maintaining a working knowledge of EU regulatory requirements and guidelines and for communicating changes in regulatory information to cross-functional teams.
Supports the remainder of the Oncology and Anti-infectives team as required.
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 and ability to work on specific tasks with minimal supervision.
Problem solving and strategic thinking skills with ability to impact and influence.
Attention to detail with accuracy and quality.
Ability to understand and effectively relate to external and internal customers.
Business awareness and professionalism.
EDUCATION and/or EXPERIENCE REQUIRED
Life Science degree and demonstrated relevant regulatory affairs experience.
Stockley Park or Cambridge.